Diagnostica Stago, Inc. Recalls

All product recalls associated with Diagnostica Stago, Inc..

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Recall Summary

Total Recalls

9

Past Year

6

Class I (Serious)

0

Most Recent

Sep 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

STA Liatest D-Di (Diagnostica Stago) – D-Dimer Level Underestimation (2025)

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

Moderate

FDASep 12, 2025Nationwide• Diagnostica Stago, Inc.

STA-Fibrinogen 5 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Moderate

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA-Liquid Anti-Xa 4 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Moderate

FDAJul 21, 2025Nationwide

• Diagnostica Stago, Inc.

STA-Liquid Anti-Xa 8 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Moderate

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA Satellite (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Moderate

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA-Owren Koller (Diagnostica Stago) – Clotting Time Inaccuracy (2025)

Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

Moderate

FDAMay 21, 2025IN, PR• Diagnostica Stago, Inc.

Diagnostica Stago, Inc.: STA R Max fully automatic clinical instrument designed to...

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).

Moderate

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

Diagnostica Stago, Inc.: STA Compact Automated Multi-Parametric Analyzer, Referenc...

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).

Moderate

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

Diagnostica Stago, Inc.: STA Compact Max fully automatic clinical analyzer, Refere...

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).

Moderate

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

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Diagnostica Stago, Inc. Recalls

Recall Summary

STA Liatest D-Di (Diagnostica Stago) – D-Dimer Level Underestimation (2025)

STA-Fibrinogen 5 (Diagnostica Stago) – Contamination Risk (2025)

STA-Liquid Anti-Xa 4 (Diagnostica Stago) – Contamination Risk (2025)

STA-Liquid Anti-Xa 8 (Diagnostica Stago) – Contamination Risk (2025)

STA Satellite (Diagnostica Stago) – Contamination Risk (2025)

STA-Owren Koller (Diagnostica Stago) – Clotting Time Inaccuracy (2025)

Diagnostica Stago, Inc.: STA R Max fully automatic clinical instrument designed to...

Diagnostica Stago, Inc.: STA Compact Automated Multi-Parametric Analyzer, Referenc...

Diagnostica Stago, Inc.: STA Compact Max fully automatic clinical analyzer, Refere...