epoc Blood Analysis BGEM Test Card
Brand(s)
Last updated
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
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Epoc Blood Analysis Bgem Test Card | Lot with prefix 02 or 12 | 10736515 |
| Epoc Blood Analysis System - Single Use Blood Gas, Electrolyte And Metabolite Test Card | 10736382, Lot prefix 00 or 06 | CT-1006-00-00 |
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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