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Kaolin Suspension

Siemens Healthcare Diagnostics Products GmbH · Model 10446033 · UDI-DI 00842768007170

KQJ
1
510(k) clearances
6
Adverse events
3
Recalls
10
Facilities

Description

Supplementary Reagent for coagulation tests

Recalls

DateFirmReason
2025-07-21Diagnostica Stago, Inc.Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
2017-05-19Fisher DiagnosticsAn 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
2017-05-19Fisher DiagnosticsAn 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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Data 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.