VITROS Immunodiagnostic Products Anti HBs Calibrators. The… recallZ-2142-2024 · Ortho-Clinical Diagnostics, Inc. · initiated Mar 1, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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 details

Recall number: Z-2142-2024
Status: Open, Classified
Initiated by the company: Mar 1, 2024
Posted by the FDA: Jun 13, 2024
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Quantity: 481 units
Product code: LOM
Distribution: 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.

Product description

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).

Code information (models, lots, serial numbers)

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).

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

VITROS 6801926
Ortho Clinical Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

How recalls are matched to devices · Editorial policy · Report an error on this page