Diagnostica Stago, Inc.: Device Recall
Recall #Z-2476-2025 · 07/21/2025
Recall Details
- Recall Number
- Z-2476-2025
- 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
- 829,800 units (245,200 US)
Reason for Recall
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Product Description
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.
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