FDA Device recall Z-0104-2024
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
- FDA Device
- Class II
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class II recall of Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 by Techno Path Manufacturing, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0104-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-25 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Techno Path Manufacturing |
| Distribution | US |
Product
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
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.
Identifiers
| code_info | a) 08P88-10, UDI/DI 05391523440776, Lot Numbers: 108032101, 110072101, 119112101, 126052201, 130112201, 131112201; b)…a) 08P88-10, UDI/DI 05391523440776, Lot Numbers: 108032101, 110072101, 119112101, 126052201, 130112201, 131112201; b) 08P88-11, UDI/DI 05391523440783, Lot Numbers: 108032102, 110072102, 119112102, 126052202, 130112202, 131112202; c) 08P88-12, UDI/DI 05391523440790, Lot Numbers: 108032103, 110072103, 119112103, 126052203, 130112203, 131112203 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0104-2024%22
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