VITROS recallZ-1227-2024 · 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-1227-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 26, 2024
- Posted by the FDA
- Mar 1, 2024
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 7 US; 4 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 3400 Chemistry System, Catalog No. 6844458
Code information (models, lots, serial numbers)
VITROS System Software Version 3.8.1 UDI-DI 10758750031986 Serial Numbers US: J34500180 J34500289 J34500422 J34500473 J34500622 J34500861 J34500887 OUS: J34500515 J34500609 J34500802 J34500940
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 6844458Ortho-Clinical Diagnostics, Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE4 recalls2 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93925).
- Z-1224-2024 · Open, ClassifiedVITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
- Z-1225-2024 · Open, ClassifiedVITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
- Z-1226-2024 · Open, ClassifiedVITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
- Z-1228-2024 · Open, ClassifiedVITROS XT 7600 Integrated System, Catalog No. 6844461
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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