E. coliPRO™

HARDY DIAGNOSTICS · Model PL070HD · UDI-DI 00819398027953

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

E. coliPRO™ O157 Latex Kit, rapid latex agglutination test for E. coli O157, 50 tests A rapid latex agglutination test kit for the identification of the E. coli O157 serotype. So sensitive that it requires only one single colony. Uses proprietary antibodies that eliminate the possibility of cross-reactions with Escherichia hermanii and other sorbitol-negative Escherichia species. Contains both positive and negative controls. Includes reaction cards and mixing sticks Each kit contains: E. coliPRO™ O157 Latex Reagent 1 dropper vial/kit E. coliPRO™ O157 Positive Control Suspension 1 dropper vial/kit E. coliPRO™ O157 Negative Control Latex Reagent 1 dropper vial/kit Latex Test Cards 20 cards/kit Mixing Sticks 75 sticks/kit

Recalls

Date	Firm	Reason
2006-08-21	Hardy Media Inc Dba Hardy Diag	Performance failure; the product is failing to show pigment development for E. coli 0157.
2002-07-18	Remel, Inc.	A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plu

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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.