FDA-Device2025-11-19Class IIPROCESSING DEFECT
Multichem ID-B. Model/Catalog 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 IgG.
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.
Affected count
76 units
Manufactured in
Fort Henry Business Park, Ballina Tipperary, Ireland
Products
Multichem ID-B. Model/Catalog 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 IgG.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0501-2026Want us to check the next one for you?
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