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U.S. Department of Health and Human Services

Class 2 Device Recall TECHNOPATH Multichem P

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  Class 2 Device Recall TECHNOPATH Multichem P see related information
Date Initiated by Firm August 25, 2023
Date Posted October 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-0106-2024
Recall Event ID 93017
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Multichem P, Part Code 08P90-10
Code Information UDI/DI 05391523440769, Lot Numbers: 04530621P, 04561021P, 04610523P
Recalling Firm/
Manufacturer		 TECHNO-PATH MANUFACTURING LTD.
Fort Henry Business Park
Ballina Tipperary Ireland
Manufacturer 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.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action LGC Group notified their sole US consignee (distribution partner) of the recall on 08/25/2023 via email. The notice explained the issue and the risk with the request to notify their end users. The end user was advised to take additional care when handling the glass vials due to the potential of breakages upon receipt, while thawing, or while opening the vials.
Quantity in Commerce 2964 units
Distribution US Nationwide distribution in the state of Illinois.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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