Medical DeviceSep 9, 2026
Diagnostica Stago STA Staclot Protein S recall — FDA Z-3047-2026
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Class IIFDA: OngoingDiagnostica Stago, Inc.
Recall history in this database
Classification mix: Class II: 19.
Medical DeviceMar 25, 2026
STA Liatest D-Di recall — FDA Z-1585-2026
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceMar 11, 2026
STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA recall — FDA Z-1491-2026
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.
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceJan 21, 2026
Diagnostica Stago Asserachrom HPIA recall — FDA Z-1084-2026
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceSep 3, 2025
Diagnostica Stago STA-Liquid Anti-Xa 4 recall — FDA Z-2474-2025
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceSep 3, 2025
Diagnostica Stago STA Satellite. Product Code: All references. All software versions. The recall — FDA Z-2473-2025
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceSep 3, 2025
Diagnostica Stago STA-Liquid Anti-Xa 8 recall — FDA Z-2475-2025
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceSep 3, 2025
Diagnostica Stago STA - Fibrinogen 5 recall — FDA Z-2476-2025
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceJun 25, 2025
Diagnostica Stago STA - Owren Koller recall — FDA Z-1993-2025
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceMay 17, 2023
Diagnostica Stago STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 recall — FDA Z-1576-2023
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…
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceMay 17, 2023
Diagnostica Stago STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 recall — FDA Z-1577-2023
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…
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceMay 17, 2023
Diagnostica Stago STA R Max fully automatic clinical instrument designed to perform tests on recall — FDA Z-1575-2023
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…
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceApr 22, 2020
Diagnostica Stago STA - Deficient VIII, Product Code: 00725 recall — FDA Z-1699-2020
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…
Class IIFDA: TerminatedDiagnostica Stago, Inc.
Medical DeviceJan 1, 2020
Diagnostica Stago STA SYSTEM CONROL N + P (ref. 00678) recall — FDA Z-0738-2020
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…
Class IIFDA: TerminatedDiagnostica Stago, Inc.
Medical DeviceJan 1, 2020
Diagnostica Stago STA UNICALIBRATOR (ref. 00675) recall — FDA Z-0737-2020
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…
Class IIFDA: TerminatedDiagnostica Stago, Inc.
Medical DeviceDec 26, 2018
Diagnostica Stago Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are recall — FDA Z-0611-2019
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.
Class IIFDA: TerminatedDiagnostica Stago, Inc.
Medical DeviceDec 26, 2018
Diagnostica Stago Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are recall — FDA Z-0610-2019
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.
Class IIFDA: TerminatedDiagnostica Stago, Inc.
Medical DeviceSep 19, 2018
Diagnostica Stago STA N¿oplastine CI, 10 ml vial recall — FDA Z-2994-2018
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Class IIFDA: TerminatedDiagnostica Stago, Inc.
Medical DeviceSep 19, 2018
Diagnostica Stago STA N¿oplastine CI Plus, 10 ml vial recall — FDA Z-2993-2018
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Class IIFDA: TerminatedDiagnostica Stago, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Diagnostica Stago, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.