Recall Z-0106-2024 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
TECHNO-PATH MANUFACTURING LTD.
Multichem P, Part Code 08P90-10
| Date | Oct 12, 2023 (initiated Aug 25, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Unknown/Undetermined by firm |
| Action | 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. |
| Quantity | 2964 units |
| Distribution | US Nationwide distribution in the state of Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.