Device product
STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss.
Z-2476-2025
Product summary
- Event
- Event 97287
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 829,800 units (245,200 US)
- Official record key
device-enforcement:Z-2476-2025
Official wording
Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Code information: Model/Catalog Number: 00674. UDI-DI: 13607450006749
Distribution pattern: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.
Derived failure modes
-
Unknown
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.