ABL90 Flex and Flex Plus
Brand(s)
Last updated
Summary
Product
ABL90 Flex and Flex Plus
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Radiometer Medical Aps
Akandevej 21, Bronshoj, Denmark, 2700
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-77178
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