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E. COLI O157 TEST KIT

OXOID LIMITED · Model DR0620M · UDI-DI 05032384013142

GNA
10
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities

Recalls

DateFirmReason
2016-11-08Meridian Bioscience IncInternal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.