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Prolex E. coli O157 Latex Test Reagent Kit (50 tests)

PRO-LAB, INCORPORATED · Model PL.070B · UDI-DI 10628429001049

510(k) clearances

Adverse events

Recalls

Facilities

Description

ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony taken directly from selective agar. This unique reagent has been developed to remove common cross reactions with other similar "O" and "H" antigens, in particular E. hermanii. Available in 50 and 100 test formats, each kit has a maximum shelf life of two years from date of manufacture, and includes mixing sticks, agglutination cards, positive and negative controls.

Recalls

Date	Firm	Reason
2016-11-08	Meridian Bioscience Inc	Internal 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.