FDA recall Z-0106-2024

TECHNO-PATH MANUFACTURING LTD. · Class II · device

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.

Distribution

US Nationwide distribution in the state of Illinois.

Key facts

Status
Ongoing
Initiation date
2023-08-25
Report date
2023-10-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ballina Tipperary, N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0106-2024