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

Recall Z-2486-2021 — SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

U.S. FDA — Device Enforcement · United States · 2021-08-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2486-2021
Date of alert
2021-08-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Microbiologics Inc
Product category
device
Product type
Devices
Reported risk: The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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