Instrumentation Laboratory recalls
Instrumentation Laboratory appears in 77 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-12.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360…
FDA Device · Class II · 2026-08-12 · Instrumentation Laboratory - 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 - 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 - 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 - 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 - 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 - 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 - 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 - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000 PAK, Part No. 00055360004
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - 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 - HemosIL SynthAFax
FDA Device · Class III · 2025-12-24 · Instrumentation Laboratory - HemosIL LMW Heparin Controls
FDA Device · Class II · 2025-08-20 · Instrumentation Laboratory - HemosIL Heparin Calibrators
FDA Device · Class II · 2025-02-05 · Instrumentation Laboratory - 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 - GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
FDA Device · Class II · 2023-11-29 · Instrumentation Laboratory - 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 - 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 - 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 - 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 - 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 - 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 - HemosIL ReadiPlasTin, Part No. 0020301400
FDA Device · Class II · 2022-05-18 · Instrumentation Laboratory - 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 - HemosIL ReadiPlasTin (20 mL), Part number 0020301400
FDA Device · Class II · 2021-12-01 · Instrumentation Laboratory - 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 - 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 - 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 - ROTEM ex-tem Canada Part No: 503-05-CA
FDA Device · Class II · 2019-09-18 · Instrumentation Laboratory - ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
FDA Device · Class II · 2019-09-18 · Instrumentation Laboratory - ROTEM ex-tem
FDA Device · Class II · 2019-09-18 · Instrumentation Laboratory - Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin…
FDA Device · Class II · 2018-10-17 · Instrumentation Laboratory