ICHEM Velocity Automated Urine Chemistry System (2019-10-28)

Starting date:

October 28, 2019

Posting date:

April 15, 2020

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-72711

Last updated: 2020-04-15

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  Reason
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  Affected products

Affected Products

1. ICHEM Velocity Automated Urine Chemistry System
2. ICHEM Velocity Automated Urine Chemistry System W Load/Unload
3. ICHEM Velocity Automated Urine Chemistry System Back Integrated

Reason

As a result of an internal investigation, Beckman Coulter has become aware of an issue affecting specific gravity chemistry settings for the ICHEM Velocity Urine Chemistry System that prevents the trigger of a chemistry system flag ""S3"" and may result in erroneous specific gravity (SG) results.

• The S3 value flag is generated when the instrument is unable to measure the specific gravity of the sample due to an interference in the sample or a hardware failure.
• The S3 value flag triggers chemistry system flags that are designed to require operator review prior to release of results.
• The ICHEMVelocity instructions for use (IFU) incorrectly states that for S3, ""the specific gravity result >1.060. This is a normal condition."" The IFU does not state that S3 value flag is generated when the instrument is unable to measure the specific gravity of the sample due to an interference in the sample or a hardware failure.

Affected products