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 Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Immunotech SAS, A Beckman Coulter Company Access TSH (3rd IS) 2x200 DET [Ref number: C28643; Lot numbers: 339117, 338724, 439341, 338367, 338057, 234251] [HKMD number: 210423].
According to the TGA, the manufacturer has received customer complaints reporting erroneously low TSH results may be generated by the lots listed above when using Access TSH (3rd IS) 2x200 DET (PN C28643) reagent packs on the DxI 9000 Access Immunoassay Analyser.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00761-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Aug 2024