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TECHNO-PATH MANUFACTURING LTD.: Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precisio

Medical DevicesSource: FDA (device) · Date: 2025-11-19

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
TECHNO-PATH MANUFACTURING LTD.
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 / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.
Recall initiated
2025-10-17
Code info
Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)261031(10) SB161024P. Lot Number: SB161024P. Expiration Date: 31-10-2026.
Product quantity
51 units
Voluntary mandated
Voluntary: Firm initiated
City
Ballina Tipperary
Country
Ireland
Event id
97800
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