Device product
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
Z-2475-2025
Product summary
- Event
- Event 97287
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 126,200 units (125,900 US)
- Official record key
device-enforcement:Z-2475-2025
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: 00322US. UDI-DI: 03607450011791
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.