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

Recall Z-0097-2023 — cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.

U.S. FDA — Device Enforcement · United States · 2022-09-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0097-2023
Date of alert: 2022-09-08
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): 07613336170076

Reported risk: Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.

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.

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.

Recall Z-0097-2023 — cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.

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