TECHNO-PATH MANUFACTURING LTD.: Device Recall
Recall #Z-0501-2026 · 10/17/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0501-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- TECHNO-PATH MANUFACTURING LTD.
- Status
- Ongoing
- Date Initiated
- 10/17/2025
- Location
- Ballina Tipperary, Ireland
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76 units
Reason for Recall
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.
Product Description
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.
Distribution Pattern
US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.
Other Recalls by TECHNO-PATH MANUFACTURING LTD.
- Class II: Risk 10/17/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.