TECHNO-PATH MANUFACTURING LTD. recalls Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control seru…

Recall date

October 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0501-2026

FDA classification

Class II

Brand / firm

TECHNO-PATH MANUFACTURING LTD.

Sold / distributed

US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.