VITROS Immunodiagnostic Products Vitamin B12 Range Verifier…

Date

June 12, 2024

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Ongoing

Filed by

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

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.

Distribution pattern

Worldwide - US Nationwide and the country of Columbia.

Quantity

76 units

Codes and lots

UDI-DI: 10758750000937 Lot Number: 1200 Exp. Date: 30-Sep-2024

Recall started

May 8, 2024

Device type

Single (Specified) Analyte Controls (Assayed And Unassayed)

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

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.

Recall number

Z-2019-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2019-2024. The agency record governs; check it and the company before acting.