Summary
Product
epoc Blood Analysis BGEM Test Card
Issue
Medical devices – Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
Issue
Siemens confirmed that the occurrence of discrepant high pH results in samples introduced with higher injection volumes (beyond the epoc reader beep or after the “analyzing sample” message is displayed) with epoc sensor configuration 45.n (software version: epoc host v3.41.2 and epoc nxs v4.14.9 & 4.14.11)
Recall start date: March 25, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products – Medical devices – Chemistry
Companies
Epocal Inc. |
2060 Walkley Road, Ottawa, Ontario, Canada, K1G 3P5 |
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-77251
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