VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
- Company
- Ortho-Clinical Diagnostics, Inc.
- Recall Initiated
- November 27, 2023
- Posted
- January 19, 2024
- Recall Number
- Z-0772-2024
- Quantity
- 6,920 US; 57 OUS
- Firm Location
- Rochester, NY
Reason for Recall
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
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 / Code Info
UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990
Root Cause
Nonconforming Material/Component
Action Taken
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.