CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report
STA - Fibrinogen recalled by Diagnostica Stago
Diagnostica Stago is recalling STA - Fibrinogen, distributed nationwide in the US. The recall was initiated on 21 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2476-2025
- FDA event ID
- 97287
- Recalling firm
- Diagnostica Stago, Parsippany, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jul 2025
- FDA classified
- 29 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Jul 2025 | Recall initiated by company | |
| 29 Aug 2025 | Classified by FDA | +39 days |
| 3 Sep 2025 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaLouisianaMarylandMaineMinnesotaMissouriMontanaNorth CarolinaOhioOklahomaOregonPennsylvaniaPuerto RicoSouth DakotaVermont
Questions about this recall
Why was it recalled?
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Which lots are affected?
Model/Catalog Number: 00674. UDI-DI: 13607450006749
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 97287This product is part of a recall event; the main page for the event is STA-Liquid Anti-Xa recalled by Diagnostica Stago.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | STA-Liquid Anti-Xa recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide | |
| CLASS II | STA Satellite recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide | |
| CLASS II | STA-Liquid Anti-Xa recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
More recalls from Diagnostica Stago
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | STA Liatest D-Di recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | STA Liatest Free Protein recalled by Diagnostica Stago | Diagnostica Stago | Device Malfunction | Nationwide |
| Device | CLASS II | Asserachrom HPIA recalled by Diagnostica Stago | Diagnostica Stago | Device Malfunction | Nationwide |
| Device | CLASS II | STA Liatest D-Di recalled by Diagnostica Stago | Diagnostica Stago | Other | Nationwide |
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