Diagnostica Stago, Inc.: Device Recall
Recall #Z-2475-2025 · 07/21/2025
Recall Details
- Recall Number
- Z-2475-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Diagnostica Stago, Inc.
- Status
- Ongoing
- Date Initiated
- 07/21/2025
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 126,200 units (125,900 US)
Reason for Recall
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Product Description
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.
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.
Other Recalls by Diagnostica Stago, Inc.
- Class II: Risk 12/15/2025
- Class II: Risk 09/12/2025
- Class II: Risk 07/21/2025
- Class II: Risk 07/21/2025
- Class II: Risk 07/21/2025