Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning ACON Biotech (Hangzhou) Co., Ltd. ACON FLOWFLEX SARS-CoV-2 [Lot Numbers with confirmed issue: COV2095027, COV2075016, COV2105020, COV2105014, COV2105020, COV2105021, COV2105024, COV2105049; Lot numbers with suspected issue: COV2105042, COV2105002, COV2105006, COV2105009, COV2105010, COV2105023, COV2105033, COV2105034, COV2105043, COV2105050, COV2105051, COV2105055, COV2105057, COV2105058, COV2115019, COV3025001, COV3025013; Device Model/Catalogue/part number(s): 1 Packs and 5 Packs] [HKMD No.: 220072].
According to the MHRA, kits manufactured for the German/Swiss markets have been re-processed by a third party and English instructions for use have been inserted into these versions of the devices without manufacturer approval. At this stage of the investigation, the manufacturer understand that the tamper evident seals for these devices are intact and therefore do not believe there is a direct impact on the product functionality or performance.
For further information, please visit https://mhra-gov.filecamp.com/s/d/S6t5eKxkEKvayWH4
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Nov 2023