FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics, Inc.: VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696
- Recall number
- Z-1664-2023
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Product
- VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696
- Status
- Open, Classified
- Initiated
- 2023-04-14
- Posted
- 2023-05-30
- Terminated
- not on file
- Reason
- Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
- Root cause
- Under Investigation by firm
- Action
- QuidelOrtho (formerly Ortho Clinical Diagnostics) issued Urgent Product Correction Notification Letter on 4/14/23 to Distributors and End/Users. Letter states reason for recall, health risk and action to take: Prior to calibrating VITROS VANC Reagent GEN 50 using VITROS Calibrator Kit 11, Lot 1172, install ADD DRV 6224 or above on your VITROS System(s). " Complete the enclosed Confirmation of Receipt form no later than April 24, 2023. " Forward this notification if VITROS Calibrator Kit 11, Lot 1172 was distributed outside of your facility. " Save this notification with your user documentation or post this notification by each VITROS 5,1 FS/4600/5600/XT 7600 System until ADD DRV 6224 or above has installed. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care" Technical Solutions Center. Contact Information If you have further questions, please contact the Ortho Care Technical Solutions Center at 1-800-421-3311.
- Quantity
- 132 units
- Distribution
- Nationwide Foreign: Brazil, Chile, Colombia
- Lot, serial or model codes
- UDI-DI: 10758750006601 Lot Number: 1172 Exp. 20-OCT-2023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DLJ
- Firm FEI
- 2250051
- Firm city
- Raritan
- Firm state
- NJ
- 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