Recall Z-0502-2026— TECHNO-PATH MANUFACTURING LTD.
Class II · Ongoing
Class II FDA medical device recall by TECHNO-PATH MANUFACTURING LTD., initiated 2025-10-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- TECHNO-PATH MANUFACTURING LTD.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-17
- Firm location
- Ballina Tipperary, Ireland
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.