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

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  Reason
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  Affected products

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