Class 2 Device Recall VITROS Immunodiagnostic Products AntiHBs Quantitative Reagent Pack and Calibrators

• Date Initiated by Firm: November 27, 2023
• Date Posted: January 19, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0772-2024
• Recall Event ID: 93632
• PMA Number: P000014
• Product Classification: Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
• Product: VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
• Code Information: UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics, Inc.; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Mr. Joe Falvo; 585-453-3452
• Manufacturer Reason for Recall: Affected lots may experience increased calibration failures or an increase in falsely elevated results.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = LOM