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 Blood Analysis BGEM Test Cards, EPOC Blood Analysis System - Single Use Blood Gas, Electrolyte and Metabolite Test Card [Model or catalog number: 10736515, CT-1006-00-00; Lot or serial number: 04-23059-50, 03-23056-50] [HKMD No.: 210419].
According to Health Canada, the manufacturer has confirmed the occurrence of discrepant high glucose results in samples with glucose results on the lower end of the reportable range (at or below 54 mg/dl) when using the above listed lots of BGEM test cards in conjunction with sensor configuration 41.1 (software version: EPOC Host v3.37.3 and EPOC NXS v4.10.6). The observed maximum bias for the affected lots are detailed in the urgent field safety notice.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/epoc-blood-analysis-system-single-use-blood-gas-electrolyte-and-metabolite-test-card
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Jun 2023