Epoc Blood Analysis Bgem Test Cards
Brand(s)
Last updated
Summary
Product
Epoc Blood Analysis Bgem Test Cards
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 catalog number |
|---|---|---|
Epoc Blood Analysis Bgem Test Cards |
112200550 |
10736515 |
Issue
Siemens Healthcare Diagnostics Inc. has confirmed the occurrence of inconsistent discrepant (low bias) po2 results. at a medical decision level of approximately 80mmhg, the maximum negative bias is - 11.7% (the acceptable bias is +/-10% for po2 range 50-250 mmhg).
Recall start date: June 8, 2022
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-64288
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