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

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  Reason
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  Affected products

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