FDAAugust 25, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

techno path manufacturingtechnotechno path

UPCs

053915234407760539152344078305391523440790

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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