FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
- Recall number
- Z-0772-2024
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Product
- VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
- Status
- Open, Classified
- Initiated
- 2023-11-27
- Posted
- 2024-01-19
- Terminated
- not on file
- Reason
- Affected lots may experience increased calibration failures or an increase in falsely elevated results.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 6,920 US; 57 OUS
- 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.
- Lot, serial or model codes
- UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990
- 510(k) numbers
- not on file
- PMA numbers
- ["P000014"]
- Product code
- LOM
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28