FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of vitamin B12 - Product Code: 6800872
- Recall number
- Z-2019-2024
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Product
- VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of vitamin B12 - Product Code: 6800872
- Status
- Open, Classified
- Initiated
- 2024-05-08
- Posted
- 2024-06-04
- Terminated
- not on file
- Reason
- The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot. As this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required.
- Root cause
- Nonconforming Material/Component
- Action
- QuidelOrtho issued IMPORTANT PRODUCT CORRECTION NOTIFICATION (Ref. CL2024-123) to Distributors and End-Users via FedEx overnight courier and/ or electronically. Letter states reason for recall, health risk and action to take: " Discontinue using, render unusable, and discard your remaining inventory of VITROS Vitamin B12 Range Verified, Lot 1200. QuidelOrtho will replace or credit your account. Indicate quantities to be replaced or credited via the Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than May 14, 2024. " Please forward this notification if the affected product was distributed outside of your facility. If you have further questions, please contact the Global Services Organization at 1-800-421-3311.
- Quantity
- 76 units
- Distribution
- Worldwide - US Nationwide and the country of Columbia.
- Lot, serial or model codes
- UDI-DI: 10758750000937 Lot Number: 1200 Exp. Date: 30-Sep-2024
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJX
- 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