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Recall Observatory FDA recall evidence

Device product

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.

Z-0501-2026

October 17, 2025

Class II

Product summary

Firm
TECHNO-PATH MANUFACTURING LTD.
Event
Event 97800
Status
Ongoing
Classification
Class II
Quantity
76 units
Official record key
device-enforcement:Z-0501-2026

Official wording

Reason: 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.

Code information: Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)260531(10)SB140524P. Lot number: SB140524P. Expiration Date: 31-5-2026

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.