VITROS recallZ-1228-2024 · Ortho-Clinical Diagnostics, Inc. · initiated Jan 26, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software Design Change

What the company is doing

On January 26, 2024, the firm sent a customer letter to all customers who have V3.8.1 installed on their VITROS Analyzer. Customers were informed of this issue and instructed to follow the instructions when using the VITROS System onboard QC package to update the QC baseline. The software will be updated to mitigate both issues within the VITROS Software QC feature. The estimated availability is 2Q2024. If you have further questions, please contact Global Services Organization at 1-800-421-3311.

Recall details

Recall number: Z-1228-2024
Status: Open, Classified
Initiated by the company: Jan 26, 2024
Posted by the FDA: Mar 1, 2024
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Quantity: 44 US; 35 OUS
Product code: JJE
FDA submissions: K182063
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.

Product description

VITROS XT 7600 Integrated System, Catalog No. 6844461

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

VITROS System Software Version 3.8.1 UDI-DI 10758750031610 Serial Numbers US: J76000199 J76001383 J76000207 J76001385 J76000353 J76001392 J76000456 J76001404 J76000459 J76001406 J76000460 J76001516 J76000468 J76001518 J76000495 J76001519 J76000502 J76001520 J76000561 J76001581 J76001207 J76001583 J76001230 J76001611 J76001231 J76001620 J76001232 J76001644 J76001235 J76001647 J76001239 J76001660 J76001260 J76001668 J76001263 J76001671 J76001270 J76001674 J76001274 J76001692 J76001331 J76001700 J76001351 J76001748 OUS: J76000118 J76001070 J76000253 J76001074 J76000265 J76001095 J76000274 J76001121 J76000281 J76001130 J76000370 J76001152 J76000447 J76001174 J76000475 J76001328 J76000620 J76001377 J76000855 J76001378 J76000856 J76001396 J76000898 J76001399 J76000901 J76001407 J76000973 J76001408 J76000976 J76001484 J76001001 J76001673 J76001027 J76001761 J76001035

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

VITROS 6844461
Ortho-Clinical Diagnostics, Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
6 recalls92 reports

Product lines

VITROSOrtho-Clinical Diagnostics, Inc. · 71 models · 806 reports · 96 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 93925).

Z-1224-2024 · Open, Classified
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Z-1225-2024 · Open, Classified
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Z-1226-2024 · Open, Classified
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Z-1227-2024 · Open, Classified
VITROS XT 3400 Chemistry System, Catalog No. 6844458

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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