Multichem ID-B — Class II medical device recall Z-0501-2026
Ongoing recall by TECHNO-PATH MANUFACTURING LTD., reported 2025-11-19, distributed in CA, CO, CT, FL, HI, IL, LA, MI…. Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control whe
| Recall number | Z-0501-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TECHNO-PATH MANUFACTURING LTD., Ballina Tipperary, Ireland |
| Recall initiated | 2025-10-17 |
| Classified | 2025-11-13 |
| Reported by FDA | 2025-11-19 |
| Distributed | CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY |
| Quantity | 76 units |
| UPC / GTIN / UDI-DI | 05391523442312 |
| Lot numbers | SB140524P |
| Model numbers | SR103B |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0501-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.