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

Recall Z-1524-2022 — ARIES SARS-CoV-2 Assay

U.S. FDA — Device Enforcement · United States · 2022-07-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1524-2022
Date of alert
2022-07-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Luminex Corporation
Product category
device
Product type
Devices
Reported risk: SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.
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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