Official recall record

VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0

US FDA — Medical Devices · 2023-10-10 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-10-10
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 10758750031986
Brand on record: Ortho-Clinical Diagnostics, Inc.
Product category: Medical Device

What the authority reported

During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

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 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2024-01-26 · US FDA — Medical Devices
VITROS XT 3400 Chemistry System, Catalog No. 6844458

Other recalls from this brand

2025-07-29 · US FDA — Medical Devices
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2025-06-10 · US FDA — Medical Devices
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/C

All 19 official recall notices naming Ortho-Clinical Diagnostics, Inc. on this site →

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