STA® - Fibrinogen 5 00674Recalls & reported problems
Diagnostica Stago · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jul 21, 2025Open, Classified
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Z-2476-2025 · Root cause: Mixed-up of materials/components · FDA record ↗
Other SYSTEM, FIBRINOGEN DETERMINATION devices
- Dade® Thrombin Reagent 10445721Siemens Healthcare Diagnostics Products GmbH · SYSTEM, FIBRINOGEN DETERMINATION1 report
- Dade® Thrombin Reagent 10445720Siemens Healthcare Diagnostics Products GmbH · SYSTEM, FIBRINOGEN DETERMINATION1 report
- Dade® Owren's Veronal Buffer 10445724Siemens Healthcare Diagnostics Products GmbH · SYSTEM, FIBRINOGEN DETERMINATION1 report
- Multifibren® U 10446691Siemens Healthcare Diagnostics Products GmbH · SYSTEM, FIBRINOGEN DETERMINATION1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.