Recall Z-0104-2024— TECHNO-PATH MANUFACTURING LTD.
Class II · Ongoing
Class II FDA medical device recall by TECHNO-PATH MANUFACTURING LTD., initiated 2023-08-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12. Reason: 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..
- Recalling firm
- TECHNO-PATH MANUFACTURING LTD.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-25
- Firm location
- Ballina Tipperary, N/A, Ireland
Product description
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.