Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0104-2024 — Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

U.S. FDA — Device Enforcement · Ireland · 2023-08-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0104-2024
Date of alert
2023-08-25
Country / jurisdiction
Ireland
Risk level
Class II
Risk type
recall
Brand
TECHNO-PATH MANUFACTURING LTD.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05391523440776
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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