iChem Velocity Automated Urine Chemistry Systems (2017-01-30)

Starting date:

January 30, 2017

Posting date:

February 27, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-62328

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  Reason
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  Affected products

Affected Products

A. iChem Velocity Automated Urine Chemistry System

B. iChem Velocity Automated Urine Chemistry System W Load/Unload

C. iChem Velocity Automated Urine Chemistry System Back Integrated

Reason

Iris International has determined that sample probe misalignment or bending on the iChem Velocity may lead to a remote possibility of false negative results due to inadequate strip dosing. The investigation was initiated based on customer complaints for control failures.

Affected products