COULTER DXH DILUENT (2015-04-10)

Starting date:

April 10, 2015

Posting date:

May 1, 2015

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-53213

• 
  Reason
• 
  Affected products

Recalled Products

A. COULTER DXH DILUENT

Reason

Beckman coulter has confirmed an increased number of complaints related to hemoglobin (HGB) on the Unicel DXH 800 and DXH 600 coulter cellular analysis systems. The investigation has revealed that the issues may be related to variability in components of the coulter DXH diluent. The use of the DXH diluent (lot numbers 3099980 - 3512190) may eventually result in a compromised HGB chamber. The use of the DXH diluent lots listed in this notice may eventually result in a compromised HGB chamber, indicated by the occurrence of events listed in the issue section. The HGB chambers are being replaced on an as needed basis. Sporadic but incorrect HGB results may be observed if your system's HGB chamber is compromised. The issue is not observed with all DXH 800 and DXH 600 systems.

Affected products