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

Recall Z-1928-2021 — Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent

U.S. FDA — Device Enforcement · United States · 2021-04-27 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1928-2021
Date of alert
2021-04-27
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Quidel Corporation
Product category
device
Product type
Devices
Reported risk: In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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