Health product recall

epoc Blood Analysis System - computing device with custom software (2019-06-11)

Starting date:
June 11, 2019
Posting date:
June 28, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70315

Last updated: 2019-06-28

Affected Products

epoc Blood Analysis System - computing device with custom software

Reason

Siemens has confirmed that a "CNC" (could not calculate) result is generated when creatinine is tested on epoc Hosts with system software version 3.30.0 (host software version 3.30.2) in a country language that uses decimal commas instead of decimal points in numbers (e.g. 1,20 compared to 1.20). This issue has been addressed in software version 3.30.1 (host software version 3.30.3).

Affected products

epoc Blood Analysis System - computing device with custom software

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

EPOC HOST

Companies
Manufacturer

Epocal Inc.

2060 Walkley Road

Ottawa

K1G 3P5

Ontario

CANADA