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Prolex E. coli O111 Latex Reagent

PRO-LAB, INCORPORATED · Model PL.1074 · UDI-DI 10628429001162

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

Description

Prolex E. coli O111 Latex Reagent

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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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.