VITROS Immunodiagnostic Products Anti HBs Calibrators…

Date

June 19, 2024

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Ortho-Clinical Diagnostics, Inc.

Product

VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).

Reason

Potential for positively biased results due to signal reduction over shelf life.

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WI, WV and the countries of Bermuda, Colombia, Singapore.

Quantity

481 units

Codes and lots

Model No. 6801926; GTIN# 10758750001699; Lot 9010 (Manufactured 13-Oct-2023; Expiry 15-Jul-2024) and 9030 (Manufactured 09-Dec-2023; Expiry 26-Aug-2024).

Recall started

March 1, 2024

Device type

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Root cause (FDA)

Under Investigation by firm

What the company told customers

Consignees were mailed an URGENT PRODUCT CORRECTION NOTIFICATION, dated 5/14/24. In this notice consignees are instructed to discontinue using, render unusable, and discard affected product. The provided notification is to be retained and posted by each VITROS System until the issue has been resolved; copies of the recall notification are to be forwarded if affected product was distributed outside your facility. Consignees are to complete and return the provided Confirmation of Receipt form no later than 5/22/24. Consignees with any questions are to contact Quidel Ortho's Global Services Organization at 1-800-421-3311.

Recall number

Z-2142-2024

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

Source: FDA · Medical device enforcement report, recall number Z-2142-2024. The agency record governs; check it and the company before acting.