FDA recall Z-0502-2026

TECHNO-PATH MANUFACTURING LTD. · Class II · device

Product

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 IgG.

Reason for recall

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-10-17
Report date
2025-11-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ballina Tipperary, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0502-2026