Medical Device Recall: VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Ortho-Clinical Diagnostics, Inc. · November 27, 2023
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.
States Affected
NATIONWIDE
Quantity Affected
6,920 US; 57 OUS
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0772-2024
Status: ongoing
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