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.
Health Canada has posted a medical device safety alert concerning Beckman Coulter, Inc. Access System Free T3 Assay, Unicel DxI 600 Access Immunoassay System Free T3 Assay and Unicel DxI 800 Access Immunoassay System Free T3 Assay [Model or Catalog Number: A13422; Lot or Serial Number: 233968] [HKMD No.: 210369].
According to Health Canada, the manufacturer is recalling specific lots of Access System Free T3 Assay, Unicel DxI 600 Access Immunoassay System Free T3 Assay and Unicel DxI 800 Access Immunoassay System Free T3 Assay. The manufacturer has identified that Access Free T3 reagent lot 233968 included an insufficient concentration of blocking reagent. Patient samples tested with Access Free T3 reagent lot 233968 may demonstrate repeatable falsely elevated results, which are caused by insufficiently blocked interferents.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/access-system-free-t3-assays
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 Mar 2023