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 DiaMed Holding GmbH DiaClon ABO/D+ Reverse-Group [Model or catalog number: 001236, 001235, 001234, 001237] [HKMD Number: 150337].
According to the Health Canada, the manufacturer would like to inform its customers that user of IH-1000 and/or IH-500 may notice a slight increase in cases of visually interpreted "4+" reactions returned as double population "DP" by these instruments when using the DiaClon ABO/D+ Reverse-Group cards.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/diaclon-abod-reverse-group
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 10 Apr 2024
Updated on 11 Apr 2024