Product Wiki · Recalls · Health Canada — Medical Devices

ABX Pentra 400 Clinical Chemistry System (2013-04-03) — recall 50405

Health Canada — Medical Devices · Canada · 2013-10-28 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
50405
Date of alert
2013-10-28
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/abx-pentra-400-clinical-chemis

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