Recall MonitorHealth Products
ABL90 Flex and Flex Plus
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: ABL90 Flex and Flex Plus
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| ABL90 Flex Plus | RWIN10 version 1.1 (933-894) RWIN10 version 1.0 (933-803) | 393-092 |
| ABL90 Flex | RWIN10 version 1.1 (933-894) RWIN10 version 1.0 (933-803) | 393-090 |
Issue
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