Recall Z-0106-2024
Techno-Path Manufacturing Ltd. · initiated August 25, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Multichem P, Part Code 08P90-10
Codes / lots: UDI/DI 05391523440769, Lot Numbers: 04530621P, 04561021P, 04610523P
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.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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.
Details
- Recall number
- Z-0106-2024
- Initiated
- August 25, 2023
- Posted by FDA
- October 12, 2023
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 2964 units
- Distribution
- US Nationwide distribution in the state of Illinois.
- Recalling firm
- Techno-Path Manufacturing Ltd., Ballina Tipperary
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0104-2024 Class II | Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the… | 08/25/2023Open, Classified |
| Z-0105-2024 Class II | Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the… | 08/25/2023Open, Classified |