Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Prod

Recalled January 31, 2024 · FDA recall Z-0772-2024 · Ortho-Clinical Diagnostics

Hazard

Affected lots may experience increased calibration failures or an increase in falsely elevated results. · FDA Class II

Units

6,920 US; 57 OUS

Sold at

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.

Description

Affected lots may experience increased calibration failures or an increase in falsely elevated results.

Product

VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926

Manufacturer(s)

Ortho-Clinical Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →