Recall Z-2476-2025
Diagnostica Stago, Inc. · initiated July 21, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model/Catalog Number: 00674. UDI-DI: 13607450006749
Reason for recall
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
FDA-determined cause: Mixed-up of materials/components
Action taken
Diagnostica Stago notified consignees on about 07/21/2025 via emailed letter titled URGENT: MEDICAL DEVICE RECALL (CORRECTION). Consignees were instructed to temporarily systematically run a quality control just before a batch of UFH or LMWH, if you run STA-LIQUID ANTI-Xa in UFH and LMWH applications on your STA SATELLITE analyzer. This request is being asked while Stago works to develop a permanent solution for the analyzer. Consignees were also requested to complete and return the Acknowledgement Form and to notify customers if affected units were transferred or further distributed.
Details
- Recall number
- Z-2476-2025
- Initiated
- July 21, 2025
- Posted by FDA
- August 28, 2025
- Product code
- KQJ – System, Fibrinogen Determination
- Quantity
- 829,800 units (245,200 US)
- Distribution
- 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…
- Recalling firm
- Diagnostica Stago, Inc., Parsippany, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2473-2025 Class II | STA Satellite. Product Code: All references. All software versions. The STA Satellite is…Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | 07/21/2025Open, Classified |
| Z-2474-2025 Class II | STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are…Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | 07/21/2025Open, Classified |
| Z-2475-2025 Class II | STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are…Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | 07/21/2025Open, Classified |