STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of th
FDA device recall Z-2476-2025 · posted 2025-08-28 · Open, Classified
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Open, Classified
- Product code
- KQJ
- Quantity affected
- 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,
- Date initiated
- 2025-07-21
- Date posted
- 2025-08-28
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIBRI-PREST AUTOMATE HA34 (K840211) | Wellcome Diagnostics | 1984-03-02 |