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 Beckman Coulter Inc Access Folate and Access TSH Reagent Packs when used on DxI 9000 Access Immunoassay Analyser [Reference numbers: A98032 and B63284; Multiple lot numbers] [HKMD No.: 200417, 210423].
According to the TGA, the manufacturer has determined that the DxI 9000 Access Immunoassay Analyser reagent pipettors may not fully puncture through the elastomeric coating on the Access Folate and Access TSH reagent pack lots listed in the table above. This issue is caused by the elastomeric coating that was used to manufacture the affected reagents.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00610-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Jul 2023