VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calib

FDA device recall Z-2019-2024 · posted 2024-06-04 · Open, Classified

Recall details

Recalling firm

Ortho-Clinical Diagnostics, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

JJX

Quantity affected

76 units

Distribution

Worldwide - US Nationwide and the country of Columbia.

Date initiated

2024-05-08

Date posted

2024-06-04

Location

Rochester, NY