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 Cortisol [Ref: 33600; Lot number: All] [HKMD No.: 210352].
According to the TGA, the manufacturer has determined that there is a problem with the Access Cortisol assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 119). The Access Cortisol APF applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. If there is no alternative method to test patient samples for Cortisol, there may be a delay in reporting patient results. Delayed patient results may result in a delayed diagnosis. Patients could be subjected to resample/retesting, particularly in children and/or neonates.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00868-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 03 Oct 2024