Official recall record

VITROS XT 7600 Integrated System, Catalog No. 6844461

US FDA — Medical Devices · 2024-01-26 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Alert date: 2024-01-26
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 10758750031610
Brand on record: Ortho-Clinical Diagnostics, Inc.
Product category: Medical Device

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 6 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2023-03-10 · US FDA — Medical Devices
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement
2024-01-26 · US FDA — Medical Devices
VITROS XT 7600 Integrated System, Catalog No. 6844461
2022-07-19 · US FDA — Medical Devices
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
2024-01-22 · US FDA — Medical Devices
VITROS XT7600 Integrated System
2023-10-10 · US FDA — Medical Devices
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0

Other recalls from this brand

2025-07-29 · US FDA — Medical Devices
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slid
2025-06-12 · US FDA — Medical Devices
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered
2025-06-10 · US FDA — Medical Devices
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.