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CLASS II · ModerateFDA

TECHNO-PATH MANUFACTURING LTD. recalls Multichem ID-B.

📅 Oct 17, 2025 · 📍 CA, CO, CT, FL, HI, IL, LA, MI +9
Recalling company
TECHNO-PATH MANUFACTURING LTD.
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.
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 17, 2025
Reported
Nov 19, 2025
Distribution
US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.
Status
Ongoing
Quantity
76 units
Lot / codes
Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)260531(10)SB140524P. Lot number: SB140524P. Expiration Date: 31-5-2026
Company location
Ballina Tipperary
Recall type
Voluntary: Firm initiated
Recall number
Z-0501-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0501-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.