Health product recall

epoc BGEM Test Card (2020-09-02)

Starting date:
September 2, 2020
Posting date:
September 18, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73927

Last updated:
2020-09-18

Affected Products

epoc BGEM Test Card

Reason

Siemens Healthcare Diagnostics has identified the occurrence of sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. For this lot, an occurrence rate of up to 17.5% discrepant (low bias) glucose results is possible with maximum observed biases.

Affected products

epoc BGEM Test Card

Lot or serial number

01-20095-10

Model or catalog number

10736515

Companies
Manufacturer

Epocal Inc.

2060 Walkley Road

Ottawa

K1G 3P5

Ontario

CANADA