Diagnostica Stago recalls
Diagnostica Stago appears in 27 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-09.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 27 |
|---|---|
| Published | 2012-11-14 to 2026-09-09 |
| By agency | FDA Device (27) |
| By classification | Class II (26), Class III (1) |
| By status | terminated (14), ongoing (13) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, US, VA, VT, WA, WI |
Recalls
- STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074
FDA Device · Class II · 2026-09-09 · Diagnostica Stago
Reason: A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified - Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic
FDA Device · Class II · 2026-03-25 · Diagnostica Stago
Reason: After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. - Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The…
FDA Device · Class II · 2026-03-11 · Diagnostica Stago
Reason: The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values. - Asserachrom HPIA. Model/Catalog Number: 00615
FDA Device · Class II · 2026-01-21 · Diagnostica Stago
Reason: Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. - Product: STA Liatest D-Di
FDA Device · Class II · 2025-10-22 · Diagnostica Stago
Reason: A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. - STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Sat…
FDA Device · Class II · 2025-09-03 · Diagnostica Stago
Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. - STA - Fibrinogen 5. Model/Catalog Number: 00674
FDA Device · Class II · 2025-09-03 · Diagnostica Stago
Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. - STA Satellite
FDA Device · Class II · 2025-09-03 · Diagnostica Stago
Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. - STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Sat…
FDA Device · Class II · 2025-09-03 · Diagnostica Stago
Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. - STA - Owren Koller
FDA Device · Class II · 2025-06-25 · Diagnostica Stago
Reason: Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% - STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
FDA Device · Class II · 2023-05-17 · Diagnostica Stago
Reason: An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the anal… - STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
FDA Device · Class II · 2023-05-17 · Diagnostica Stago
Reason: An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the anal… - STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
FDA Device · Class II · 2023-05-17 · Diagnostica Stago
Reason: An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the anal… - STA - Deficient VIII, Product Code: 00725
FDA Device · Class II · 2020-04-22 · Diagnostica Stago
Reason: A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased - STA SYSTEM CONROL N + P (ref. 00678)
FDA Device · Class II · 2020-01-01 · Diagnostica Stago
Reason: A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observ… - STA UNICALIBRATOR (ref. 00675)
FDA Device · Class II · 2020-01-01 · Diagnostica Stago
Reason: A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observ… - Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus…
FDA Device · Class II · 2018-12-26 · Diagnostica Stago
Reason: There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. - Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus an…
FDA Device · Class II · 2018-12-26 · Diagnostica Stago
Reason: There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. - Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial
FDA Device · Class II · 2018-09-19 · Diagnostica Stago
Reason: QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) - Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial
FDA Device · Class II · 2018-09-19 · Diagnostica Stago
Reason: QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) - STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT)
FDA Device · Class II · 2018-03-21 · Diagnostica Stago
Reason: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). - Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT)
FDA Device · Class II · 2018-03-21 · Diagnostica Stago
Reason: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). - Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT)
FDA Device · Class II · 2018-03-21 · Diagnostica Stago
Reason: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). - STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT)
FDA Device · Class II · 2018-03-21 · Diagnostica Stago
Reason: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). - Stago IVD, Liquid Anti-Xa, NDC 3607450003116
FDA Device · Class III · 2014-09-24 · Diagnostica Stago
Reason: Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers. - Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex D…
FDA Device · Class II · 2013-03-20 · Diagnostica Stago
Reason: Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result. - STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the perfor…
FDA Device · Class II · 2012-11-14 · Diagnostica Stago
Reason: Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printin…