Multichem P — Class II medical device recall Z-0106-2024
Ongoing recall by TECHNO-PATH MANUFACTURING LTD., reported 2023-10-18, distributed nationwide. Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem
| Recall number | Z-0106-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TECHNO-PATH MANUFACTURING LTD., Ballina Tipperary, N/A, Ireland |
| Recall initiated | 2023-08-25 |
| Classified | 2023-10-12 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 2,964 units |
| Reason classes | foreign material, packaging, temperature control, device malfunction |
| UPC / GTIN / UDI-DI | 05391523440769 |
| Lot numbers | 04530621P, 04561021P, 04610523P |
| Model numbers | 08P90-10 |
Product
Multichem P, Part Code 08P90-10
Reason for recall
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.
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-0106-2024. 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.