Recall Z-2019-2024 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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
| Date | Jun 4, 2024 (initiated May 8, 2024) |
| Status | Open, Classified |
| 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. We |
| 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 notificatio |
| Quantity | 76 units |
| Distribution | Worldwide - US Nationwide and the country of Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.