FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0502-2026
·
Reported November 19, 2025
Enforcement
- Recall Number
- Z-0502-2026
- Event ID
- 97800
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- TECHNO-PATH MANUFACTURING LTD.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- November 19, 2025
- Initiation Date
- October 17, 2025
- Classification Date
- November 13, 2025
- Address
- Fort Henry Business Park, Ballina Tipperary, N/A, Ireland
Description
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
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 Info
Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)261031(10) SB161024P. Lot Number: SB161024P. Expiration Date: 31-10-2026.
Distribution
US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.
Quantity
51 units