Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1033-2017 — PREMIER EHEC and PREMIER EHEC Bulk.

U.S. FDA — Device Enforcement · United States · 2016-11-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1033-2017
Date of alert
2016-11-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Meridian Bioscience Inc
Product category
device
Product type
Devices
Reported risk: Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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