Recall Z-0772-2024
Ortho-Clinical Diagnostics, Inc. · initiated November 27, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Codes / lots: UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990
Reason for recall
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
FDA-determined 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.
Details
- Recall number
- Z-0772-2024
- Initiated
- November 27, 2023
- Posted by FDA
- January 19, 2024
- Product code
- LOM – Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- 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.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc., Rochester, NY