Instrumentation Laboratory recalls
Instrumentation Laboratory appears in 79 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 79 |
|---|---|
| Published | 2012-09-26 to 2026-10-21 |
| By agency | FDA Device (79) |
| By classification | Class II (76), Class I (2), Class III (1) |
| By status | ongoing (48), terminated (31) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV |
Recalls
- HemoslL AcuStar HIT-lgG(PF-4)
FDA Device · Class I · 2026-10-21 · Instrumentation Laboratory
Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. - HemoslL AcuStar HIT-lgG(PF-4)
FDA Device · Class I · 2026-10-21 · Instrumentation Laboratory
Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. - GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360…
FDA Device · Class II · 2026-08-12 · Instrumentation Laboratory
Reason: The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management… - GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The G…
FDA Device · Class II · 2026-08-12 · Instrumentation Laboratory
Reason: The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition a… - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory
Reason: Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Manag…
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory
Reason: Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory
Reason: Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable bloo…
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory
Reason: Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory
Reason: Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory
Reason: Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000 PAK, Part No. 00055360004
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consec… - The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy
FDA Device · Class II · 2026-01-21 · Instrumentation Laboratory
Reason: Potential for microbial contamination. - HemosIL SynthAFax
FDA Device · Class III · 2025-12-24 · Instrumentation Laboratory
Reason: Recalled lots were manufactured with double the amount of preservative concentration. - HemosIL LMW Heparin Controls
FDA Device · Class II · 2025-08-20 · Instrumentation Laboratory
Reason: Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liqui… - HemosIL Heparin Calibrators
FDA Device · Class II · 2025-02-05 · Instrumentation Laboratory
Reason: Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range. - GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
FDA Device · Class II · 2023-11-29 · Instrumentation Laboratory
Reason: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled perform… - GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
FDA Device · Class II · 2023-11-29 · Instrumentation Laboratory
Reason: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled perform… - GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360…
FDA Device · Class II · 2023-11-29 · Instrumentation Laboratory
Reason: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled perform… - ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolys…
FDA Device · Class II · 2023-09-20 · Instrumentation Laboratory
Reason: Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result - ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysi…
FDA Device · Class II · 2023-04-05 · Instrumentation Laboratory
Reason: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments - ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis tes…
FDA Device · Class II · 2023-04-05 · Instrumentation Laboratory
Reason: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments - ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing
FDA Device · Class II · 2023-04-05 · Instrumentation Laboratory
Reason: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments - ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing
FDA Device · Class II · 2023-04-05 · Instrumentation Laboratory
Reason: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments - HemosIL ReadiPlasTin, Part No. 0020301400
FDA Device · Class II · 2022-05-18 · Instrumentation Laboratory
Reason: Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin… - ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished…
FDA Device · Class II · 2022-05-04 · Instrumentation Laboratory
Reason: Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in t… - HemosIL ReadiPlasTin (20 mL), Part number 0020301400
FDA Device · Class II · 2021-12-01 · Instrumentation Laboratory
Reason: The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or… - HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular we…
FDA Device · Class II · 2021-10-27 · Instrumentation Laboratory
Reason: Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days - HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular we…
FDA Device · Class II · 2021-10-27 · Instrumentation Laboratory
Reason: Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days - HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories
FDA Device · Class II · 2021-10-27 · Instrumentation Laboratory
Reason: Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days - ROTEM ex-tem Canada Part No: 503-05-CA
FDA Device · Class II · 2019-09-18 · Instrumentation Laboratory
Reason: Prolonged clotting times - ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
FDA Device · Class II · 2019-09-18 · Instrumentation Laboratory
Reason: Prolonged clotting times