ABX Pentra 400 Clinical Chemistry System - Controls (2013-12-05)

Starting date:

December 5, 2013

Posting date:

January 24, 2014

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-37637

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  Reason
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  Affected products

Recalled products

1. ABX Pentra 400 Clinical Chemistry System - Controls

Reason

During a complaint investigation at the manufacturer (Horiba ABX SAS), a shift in the target value of the ABX Pentra N control was detected for Potassium-E values related to the ABX Pentra 400 only. Clinical laboratories will observe the Potassium N control result will be reported in the lower range of the N control target range. The original target value annex shipped with the ABX Pentra N control lot: 1300801 identified the potassium target value as 4.00 mmol/L with a target range of 3.70 - 4.30 mmol/l (equivalent to 15.6 mg/dL with a target range of 14.4 - 16.8 mg/dL).

Horiba ABX SAS (the manufacturer) has reassigned the target value and range and updated the annex for this lot number to reflect a target value of 3.76 mmol/L and a target range of 3.46 - 4.06 mmol/L (equivalent to 14.7 mg/dL with a target range of 13.5 - 15-.9 mg/dL) for potassium. This issue is only applicable to Potassium-E values reported on the ABX Pentra 400 chemistry analyzer with the ISE module only. No other analyzers or other analyte values are affected.

Affected products