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 | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results. |
| Product | Multichem P, Part Code 08P90-10 |
| Quantity | 2964 units |
| Distribution | US Nationwide distribution in the state of Illinois. |
| Initiated | 2023-08-25 |
| Classified | 2023-10-12 |
| Recall number | Z-0106-2024 |
| 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-0106-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93017/
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