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

Recall Z-1075-2024 — Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.

U.S. FDA — Device Enforcement · United States · 2024-01-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1075-2024
Date of alert
2024-01-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Microbiologics Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
70845357041448
Reported risk: The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control.
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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