FDAHealthOctober 17, 2025
TECHNO-PATH MANUFACTURING LTD. — Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory test
⚠️ 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.
Is this relevant to me?
- Geography
- US, CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY
- Source agency
- FDA
- Category
- Health
- Published
- October 17, 2025
US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.
What's affected?
- 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.
- Lot code
- SB140524P
Additional details
Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)260531(10)SB140524P. Lot number: SB140524P. Expiration Date: 31-5-2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 76 units.
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