Recall Z-2476-2025— Diagnostica Stago, Inc.
Class II · Ongoing
Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2025-07-21. It names one FDA 510(k) clearance: K840211. 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.. Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications..
- Recalling firm
- Diagnostica Stago, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-21
- Firm location
- Parsippany, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.