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

Recall Z-1267-2021 — VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleo

U.S. FDA — Device Enforcement · United States · 2021-02-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1267-2021
Date of alert: 2021-02-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ortho-Clinical Diagnostics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10758750033584

Reported risk: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.

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