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Dade Data-Fi Abnormal Fibrinogen Control
Siemens Healthcare Diagnostics Products GmbH · Model 10873836 · UDI-DI 00630414640150
1
510(k) clearances
6
Adverse events
3
Recalls
10
Facilities
Description
Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low range
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-21 | Diagnostica Stago, Inc. | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| 2017-05-19 | Fisher Diagnostics | An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While |
| 2017-05-19 | Fisher Diagnostics | An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.