Class II — TECHNO-PATH MANUFACTURING LTD.
| Recalling firm | Techno-path Manufacturing Ltd. |
|---|---|
| Registered facility | TECHNO-PATH MANUFACTURING LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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. |
| Quantity | 76 units |
| Distribution | US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY. |
| Initiated | 2025-10-17 |
| Classified | 2025-11-13 |
| Recall number | Z-0501-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — TECHNO-PATH MANUFACTURING LTD. (Z-0501-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97800/
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