FDA Medical Device Recalls (openFDA)
Ortho Clinical Diagnostics: VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
- Recall number
- Z-2185-2019
- Recalling firm
- Ortho Clinical Diagnostics
- Product
- VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
- Status
- Terminated
- Initiated
- 2019-07-08
- Posted
- not on file
- Terminated
- 2023-10-19
- Reason
- Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Root cause
- Software design
- Action
- 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.
- Quantity
- not on file
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
- Lot, serial or model codes
- product code:6844508 UDI: 10758750032105 Affected Assay Data Disk (ADD) DRV No: DRV 6032 or above
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JIX
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28