VITROS recallZ-0652-2019 · Ortho-Clinical Diagnostics · initiated Oct 19, 2018
Terminated
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 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
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
On October 19, 2018, Ortho Clinical Diagnostics issued "URGENT PRODUCT CORRECTION NOTIFICATION" notices via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers to inform them of the issue and actions to take to prevent occurrence of the anomaly. On November 19, 2018 Ortho Clinical Diagnostics re-issued correction notices to customers pertaining to the 5,1 FS system (CL2018-194_5,1FS). Customers may continue using their VITROS Systems and have been informed that the software issue will be mitigated with the next version of software. The expected dates of these software versions are included in the communication. Foreign affiliates were informed by email approximately on 21 October 2018 of the issue and instructed to notify their consignees of the issue and required actions to prevent the occurrence of the anomaly. Please refer to the Customer letter (Ref. CL2018-194_51FS, CL2018-194_3600, CL2018-194_4600, and CL2018-194_5600) for specific details on Required Actions by User. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Recall details
- Recall number
- Z-0652-2019
- Status
- Terminated
- Initiated by the company
- Oct 19, 2018
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 682
- Product code
- JJE
- FDA submissions
- K083173
- Distribution
- US Nationwide Distribution
Product description
VITROS 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Code information (models, lots, serial numbers)
Product Code: 6802783 UDI 10758750002979 Product Code: 6802914 UDI 10758750007103 Serial Numbers: J36000109-J36001169
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 6802783Ortho-Clinical Diagnostics, Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE8 recalls8 reports
- VITROS 6802914Ortho-Clinical Diagnostics, Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE6 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 81563).
- Z-0650-2019 · TerminatedVITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical int…
- Z-0653-2019 · TerminatedVITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (d…
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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