UNICEL DXH 800/600 COULTER CELLULAR ANALYSIS SYSTEM (2016-08-08)

Starting date:

August 8, 2016

Posting date:

August 19, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Hospitals, General Public, Healthcare Professionals

Identification number:

RA-59890

• 
  Reason
• 
  Affected products

Affected products

1. UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
2. UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM

Reason

Results from a patient control sample could be misidentified by being associated with a pending test order for a patient sample already on the worklist when the following sequence of events occurs:

- the primary identifier is tube position ID

- a patient control file is setup for ID xxxxx, and a pending test order for a patient sample ID xxxxx is subsequently added to the worklist

- the patient control sample is analyzed using cassette presentation, but that tube does not contain a barcode-labeled specimen ID or the label cannot be read.

Affected products