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

Recall Z-0450-2021 — VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product C

U.S. FDA — Device Enforcement · United States · 2020-09-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0450-2021
Date of alert: 2020-09-30
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): 10758750033362

Reported risk: Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control

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.

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