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
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990
Products Sold
UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Imm due to Affected lots may experience increased calibration failures or an increase in falsely elevated results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026