ABX Pentra 400 Clinical Chemistry System (2013-04-03)

Starting date:

April 3, 2013

Posting date:

October 28, 2013

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-36415

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  Reason
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  Affected products

Recalled Products

ABX Pentra 400 Clinical Chemistry System

Reason

As per the manufacturer, during a complaint investigation, it was determined that the ABX Pentra 400 does not provide a low or high out of linearity range flag for ISE results (i.e. sodium, chloride, and potassium). The only flag that is present in these situations is the ref-range_low or _high analysis flags and an "l" or "h" flag on the patient report. There was no alarm informing the user that the value was outside of the instrument's linearity limits. The lack of an out of linearity range flag without any indication that the results may actually be invalid due to the linearity limits being exceeded. This is a software design oversight for the ABX Pentra 400 I.S.E. Module instruments.

Affected products