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

Recall Z-1515-2022 — cobas e801 Immunoassay Analyzer

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-1515-2022
Date of alert
2022-07-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diagnostics Operations, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613336158456
Reported risk: Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.
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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.