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.
| Posting Date | Description of Product | Source of Information * |
|---|---|---|
| 23 Nov 2023 | 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] | MHRA |
| Posting Date | Title |
|---|
* FDA = Food and Drug Administration, United States of America;
MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada;
TGA = Therapeutic Goods Administration, Australia;
HPRA = Health Products Regulatory Authority, Ireland;
HSA = Health Sciences Authority, Singapore