FDA Medical devices recall ·
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed… recall
- Recall number
- Z-0502-2026
- Date
- (initiated October 17, 2025)
- Company / brand
- Techno-Path Manufacturing Ltd.
Fort Henry Business Park, Ballina Tipperary, Ireland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 51 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: California Colorado Connecticut Florida Hawaii Illinois Louisiana Michigan Minnesota Nevada New York Oregon South Carolina Tennessee Texas Wisconsin Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0502-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.