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

Recall Z-0083-2022 — cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190

U.S. FDA — Device Enforcement · United States · 2021-09-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0083-2022
Date of alert
2021-09-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Molecular Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07248563190
Reported risk: False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
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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