VITROS Immunodiagnostic Products Anti-HBs Quantitative… recallZ-0772-2024 · Ortho-Clinical Diagnostics, Inc. · initiated Nov 27, 2023
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
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 27 November 2023, consignees who had been shipped the affected VITROS Anti-HBs Reagent Pack and Calibrator were notified of the issue via Urgent Production Correction Notification letters. Customers were instructed to immediately discontinue using, render unusable, and discard all affected lots of the affected product from their inventory. - QuidelOrtho will provide credit or replacement for the discarded product. - QuidelOrtho recommends a review of previous results between 12-30 mIU/mL, which were generated using an affected lot of VITROS anti-HBs Reagent Pack, where only anti-HBs testing was performed and was positive (for example, postvaccination testing) or where only anti-HBs was positive in the triple-panel test. If you have further questions, please contact QuidelOrtho's Global Services Organization (formerly Ortho Care) at 1-800-421-3311.
Recall details
- Recall number
- Z-0772-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 27, 2023
- Posted by the FDA
- Jan 19, 2024
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 6,920 US; 57 OUS
- Product code
- LOM
- FDA submissions
- P000014
- Distribution
- Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, France, Belgium, and The Netherlands.
Product description
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Code information (models, lots, serial numbers)
UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 6801925Ortho Clinical Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)1 recall15 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.
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