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

Recall Z-1233-2024 — VITROS XT 7600 Integrated System, Catalog No. 6844461

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-1233-2024
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)
10758750031610
Reported risk: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which 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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