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 Instrumentation Laboratory Co. Gem Premier 3500, 4000, 5000 [Multiple model or catalog numbers; Multiple lot or serial numbers] [HKMD No.: 200446].
According to Health Canada, internal testing identified that the Gem Paks (cartridges) for the Gem Premier 3x00 with IGM, Gem Premier 4000 with IGM, and Gem Premier 5000 with IGM2 of impacted cartridge lots may experience an increase in Calibration Valuation Product (CVP) (Gem Premier 4000 Paks and Gem Premier 3x00 Paks) or Auto Pak Validation (Gem Premier 5000 paks) po2 failures. If the Pak passes CVP or completes warm-up for po2, the Gem Pak may remain in use.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/gem-paks
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 Nov 2023