Health product recall

Epoc Blood Analysis Bgem Test Cards

Brand(s)
Last updated

Summary

Product
Epoc Blood Analysis Bgem Test Cards
Issue
Medical devices - Performance issue
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: 2022-06-23
Alert / recall type
Health product recall
Category
Health product - Medical device - 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