Unicel DXH 600 and 800 Systems (2013-10-31)

Starting date:

October 31, 2013

Posting date:

December 17, 2013

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-37193

• 
  Reason
• 
  Affected products

Recalled products

1. Unicel DXH 800 Coulter Cellular Analysis System
2. Unicel DXH 600 Coulter Cellular Analysis System

Reason

Sample analysis cycle time for specimen with high white blood cell (WBC) counts (approximately 45.0 x 103 /uL or higher) is approximately two (2) minutes longer than expected for the DXH analytical systems with the software revisions Unicel DXH 800 Coulter cellular analysis system, software revision 2.0.2.1 and unicel DXH 600 Coulter cellular analysis system, software revision 1.0. The original total sample analysis cycle time (analysis and cleaning cycle) was approximately two and a half (2 1/2) minutes while the current cycle time is approximately five and a half (5 1/2) minutes. Test results are not affected by this issue.

Affected products