Health product recall

ABL90 Flex and Flex Plus

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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