COULTER DILUENTS (2015-09-04)

Starting date:

September 4, 2015

Posting date:

October 14, 2015

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-55340

• 
  Reason
• 
  Affected products

Affected Products

1. COULTER ISOTON III DILUENT
2. COULTER LH SERIES DILUENT

Reason

Beckman Coulter has received an increased number of complaints related to the hemoglobin (Hgb) parameter on the Coulter LH 500 and Coulter HmX Hematology Systems. The investigation has revealed that the issues may be related to variability in a component of the Coulter ISOTON III and Coulter LH Series diluent reagents which in turn may lead to a film coating the inside of the white blood cell (WBC) bath where Hgb is measured. The use of the affected diluent lots may result in symptoms including:

1. Failures in Hgb background at startup or during a background cycle
2. Increases in incomplete computations (...) for Hgb

Affected products