Multichem S Plus recallZ-0104-2024 · Techno-Path Manufacturing Ltd. · initiated Aug 25, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Techno-Path Manufacturing Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
LGC Group notified their sole US consignee (distribution partner) of the recall on 08/25/2023 via email. The notice explained the issue and the risk with the request to notify their end users. The end user was advised to take additional care when handling the glass vials due to the potential of breakages upon receipt, while thawing, or while opening the vials.
Recall details
- Recall number
- Z-0104-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 25, 2023
- Posted by the FDA
- Oct 12, 2023
- Recalling firm
- Techno-Path Manufacturing Ltd.
- Quantity
- 117155 units
- Product code
- JJY
- Distribution
- US Nationwide distribution in the state of Illinois.
Product description
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
Code information (models, lots, serial numbers)
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
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Multichem S Plus 08P88-10Techno-Path Manufacturing Limited · Multi-Analyte Controls Unassayed1 recall0 reports
- Multichem S Plus 08P88-11Techno-Path Manufacturing Limited · Multi-Analyte Controls Unassayed1 recall0 reports
- Multichem S Plus 08P88-12Techno-Path Manufacturing Limited · Multi-Analyte Controls Unassayed1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93017).
- Z-0105-2024 · Open, ClassifiedMultichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19
- Z-0106-2024 · Open, ClassifiedMultichem P, Part Code 08P90-10
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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