FDAOctober 17, 2025device
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
What to do
FDA enforcement status: Ongoing
Brands named
techno path manufacturingtechnotechno path
UPCs
05391523442312
Recall history
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