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CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH

DIESSE DIAGNOSTICA SENESE SPA · Model 82306 · UDI-DI 08033891322748

MCB
10
510(k) clearances
9
Adverse events
4
Recalls
8
Facilities

Recalls

DateFirmReason
2021-09-22bioMerieux, Inc.bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed result
2007-12-04Biosite IncFalse Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed wi
2002-12-26Meridian Bioscience IncDue to defective packaging, the firm cannot assure product stability through the labeled expiration date.
2002-12-26Meridian Bioscience IncDue to defective packaging, the firm cannot assure product stability through the labeled expiration date.

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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.