VITROS recallZ-1225-2024 · 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-1225-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 26, 2024
- Posted by the FDA
- Mar 1, 2024
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 4 US; 18 OUS
- Product code
- JJE
- FDA submissions
- K031924
- 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 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Code information (models, lots, serial numbers)
VITROS System Software Version 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201 Serial Numbers US: J46000240 J46000898 J46001030 J46001293 OUS: J46000150 J46001041 J46000190 J46001042 J46000499 J46001186 J46000564 J46001187 J46000801 J46001210 J46000821 J46001217 J46000910 J46001289 J46000933 J46001639 J46001029 J46001645
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 6802445Ortho-Clinical Diagnostics, Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE9 recalls18 reports
- VITROS 6900440Ortho-Clinical Diagnostics, Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE5 recalls0 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-1226-2024 · Open, ClassifiedVITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
- Z-1227-2024 · Open, ClassifiedVITROS XT 3400 Chemistry System, Catalog No. 6844458
- 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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