Health Canada — Medical Devices · Canada · 2025-03-25 · Type II
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Reported risk: There is a potential risk with ABL90 Flex & ABL90 Flex Plus running RWIN10 1.0 and RWIN10 1.1. The issue is that the analyzer software may unexpectedly freeze during a sample measurement. The analyzer software includes a watchdog that detects a freeze and automatically restarts the software. If the analyzer freezes, a sample being processed will be lost. Recall Start Date: March 11, 2025
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