VITROS recallZ-2185-2019 · Ortho Clinical Diagnostics · initiated Jul 8, 2019
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
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
FDA root cause category: Software design
What the company is doing
Customers were notified prior to July 10, 2019. For the VITROS 250, 250AT, and 350 chemistry system: Do not use VITROS Calibrator Kit 32 to calibrate assays until an Ortho trained service personnel reconfigures your system(s) with the correct parameters for VITROS Calibrator Kit 32. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification by each system that may use VITROS Calibrator Kit 32 until your system is reconfigured by an Ortho trained representative. Please forward this notification if the product was distributed outside of your facility. For the VITROS 4600,5600 and 5,1 FS chemistry System: If your system is configured with User Modified parameters, choose an option provided in the Interim Resolutions section listed above. Install ADD DRV 6040 or above upon availability. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification either by each system that processes VITROS Calibrator Kit 32 or with your user documentation until DRV 6040 or above is installed on your system(s). Please forward this notification if the product was distributed outside of your facility. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Recall details
- Recall number
- Z-2185-2019
- Status
- Terminated
- Initiated by the company
- Jul 8, 2019
- Recalling firm
- Ortho Clinical Diagnostics
- Product code
- JIX
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
Product description
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Code information (models, lots, serial numbers)
product code:6844508 UDI: 10758750032105 Affected Assay Data Disk (ADD) DRV No: DRV 6032 or above
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 6844508Ortho-Clinical Diagnostics, Inc. · Calibrator, multi-analyte mixture2 recalls7 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 83322).
- Z-2175-2019 · TerminatedVITROS 250 Chemistry System, clinical chemistry analyzer
- Z-2177-2019 · TerminatedVITROS 350 Chemistry System, clinical chemistry analyzer
- Z-2178-2019 · TerminatedVITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
- Z-2179-2019 · TerminatedVITROS 5600 Integrated System, clinical chemistry analyzer
- Z-2180-2019 · TerminatedVITROS 5600 Integrated System, clinical chemistry analyzer
- Z-2181-2019 · TerminatedVITROS 4600 Chemistry System, clinical chemistry analyzer
- Z-2182-2019 · TerminatedVITROS 4600 Chemistry System, clinical chemistry analyzer
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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