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

Recall Z-1226-2024 — VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

U.S. FDA — Device Enforcement · United States · 2024-01-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1226-2024
Date of alert
2024-01-26
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)
10758750002740
Reported risk: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
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.