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Diagnostica Stago Recalls
26 recalls on record · November 14, 2012 to March 25, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 25, 2026Medical DevicesFDA
Diagnostica Stago, Inc. recalls Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in v
Hazard: After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
March 11, 2026Medical DevicesFDA
Diagnostica Stago, Inc. recalls Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Pro
Hazard: 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.
January 21, 2026Medical DevicesFDA
Diagnostica Stago, Inc. recalls Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection i
Hazard: Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
October 22, 2025Medical DevicesFDA
Diagnostica Stago, Inc. recalls Product: STA Liatest D-Di; REF: 00515;
Hazard: A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
September 3, 2025Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers o
Hazard: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
September 3, 2025Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R,
Hazard: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
September 3, 2025Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, S
Hazard: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
September 3, 2025Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop a
Hazard: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
June 25, 2025Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent
Hazard: Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
May 17, 2023Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
Hazard: 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 analyzer (error 13).
May 17, 2023Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Hazard: 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 analyzer (error 13).
May 17, 2023Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59
Hazard: 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 analyzer (error 13).
April 22, 2020Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in
Hazard: 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
January 1, 2020Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA SYSTEM CONROL N + P (ref. 00678)
Hazard: 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 observed on several External Quality Assessment (EQA) results.
January 1, 2020Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA UNICALIBRATOR (ref. 00675)
Hazard: 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 observed on several External Quality Assessment (EQA) results.
December 26, 2018Medical DevicesFDA
Diagnostica Stago, Inc. recalls Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitat
Hazard: 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.
December 26, 2018Medical DevicesFDA
Diagnostica Stago, Inc. recalls Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitativ
Hazard: 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.
September 19, 2018Medical DevicesFDA
Diagnostica Stago, Inc. recalls Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) i
Hazard: QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
September 19, 2018Medical DevicesFDA
Diagnostica Stago, Inc. recalls Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time
Hazard: QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
March 21, 2018Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (
Hazard: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
March 21, 2018Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Hazard: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
March 21, 2018Medical DevicesFDA
Diagnostica Stago, Inc. recalls Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
Hazard: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
March 21, 2018Medical DevicesFDA
Diagnostica Stago, Inc. recalls Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Hazard: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
September 24, 2014Medical DevicesFDA
Diagnostica Stago, Inc. recalls Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Comp
Hazard: Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
March 20, 2013Medical DevicesFDA
Diagnostica Stago, Inc. recalls Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago
Hazard: Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
November 14, 2012Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and i
Hazard: 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 printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite¿.