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 Epocal Inc. Epoc Bgem Bun Test Card [25pk] [Model or catalogue number: 10736515; Lot or serial number: 08-24092-60] [HKMD No.: 210419].
According to Health Canada, the manufacturer has confirmed that a negative sodium bias may exist in some card lots approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/l. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. Please note the card lots identified are now expired.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/epoc-bgem-bun-test-card-25pk
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 07 Oct 2024