Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926

Hazard

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

Details from the source

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. Quantity: 6,920 US; 57 OUS Lot/code info: UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990

UPC codes

10758750001682

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.