| 2026-02-05 |
Class II
|
Ongoing |
Z-1585-2026 |
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The … |
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After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. |
| 2026-02-04 |
Class II
|
Ongoing |
Z-1491-2026 |
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Pro… |
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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. |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1084-2026 |
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection i… |
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Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. |
| 2025-09-12 |
Class II
|
Ongoing |
Z-0205-2026 |
Product: STA Liatest D-Di; REF: 00515; |
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A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. |
| 2025-07-21 |
Class II
|
Ongoing |
Z-2476-2025 |
STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers o… |
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Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| 2025-07-21 |
Class II
|
Ongoing |
Z-2475-2025 |
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, … |
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Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| 2025-07-21 |
Class II
|
Ongoing |
Z-2474-2025 |
STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, S… |
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Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| 2025-07-21 |
Class II
|
Ongoing |
Z-2473-2025 |
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop a… |
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Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| 2025-05-21 |
Class II
|
Ongoing |
Z-1993-2025 |
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent… |
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Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% |
| 2023-03-22 |
Class II
|
Ongoing |
Z-1577-2023 |
STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612 |
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An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased freque… |
| 2023-03-22 |
Class II
|
Ongoing |
Z-1576-2023 |
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612 |
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An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased freque… |
| 2023-03-22 |
Class II
|
Ongoing |
Z-1575-2023 |
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59… |
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An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased freque… |
| 2020-03-04 |
Class II
|
Terminated |
Z-1699-2020 |
STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in … |
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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 facto… |