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

Recall Z-2480-2020 — VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979

U.S. FDA — Device Enforcement · United States · 2020-05-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2480-2020
Date of alert
2020-05-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho Clinical Diagnostics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10758750002979
Reported risk: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
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.