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TECHNO-PATH MANUFACTURING LTD. recalls Multichem P, Part Code 08P90-10

Recalled October 18, 2023 · FDA recall Z-0106-2024 · TECHNO-PATH MANUFACTURING

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. · FDA Class II
Units
2964 units
Sold at
US Nationwide distribution in the state of Illinois.

Description

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.

Product
Multichem P, Part Code 08P90-10
Manufacturer(s)
TECHNO-PATH MANUFACTURING LTD.
Made in
Ireland

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

TECHNO-PATH MANUFACTURING LTD. recalls Multichem P, Part Code 08P90-10 | RecallWatchUSA