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

Recall Z-2039-2025 — Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.

U.S. FDA — Device Enforcement · United States · 2025-05-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2039-2025
Date of alert
2025-05-09
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)
10758750012343
Reported risk: a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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