FDA-Device2023-10-18Class II

Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

TECHNO-PATH MANUFACTURING LTD.

Hazard

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.

Sold states

US Nationwide distribution in the state of Illinois.

Affected count

117155 units

Manufactured in

Fort Henry Business Park, N/A, Ballina Tipperary, N/A, Ireland

Products

Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0104-2024

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