Recall Z-0502-2026 ยท OHQ Multi-Analyte Controls Unassayed
TECHNO-PATH MANUFACTURING LTD.
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.
| Date | Nov 14, 2025 (initiated Oct 17, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | LGC Clinical Diagnostics notified consignees on about 10/17/2025 via letter that Techno-path Manufacturing Ltd was recalling specific Multichem ID-B products. Consignee were informed that the Instructions for Use (IFU) for Multichem ID-B SR103B, Lots SB140524P and SB161024P have been updated to remove the representative reactivity for the analyte HBsAg; therefore, no representative reactivity result will be provided for HBsAg in these lots. Consignees were instructed to discard all previous versions of the IFU for affected lots, share the information with all applicable laboratory staff or c |
| Quantity | 51 units |
| Distribution | US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.