FDA Device

COULTER LH 700 Series Hematology Analyzers

Hazard

Software vote out logic changed. Erroneous white blood cell counts.

What You Should Do

Remedy

Customers received a telephone call and a faxed Product Corrective Action letter dated Nov. 8, 2002 which includes modified operating instructions. Additionally an updated software version was released and installed on all affected customers units. This recall is complete.

Products

COULTER LH 700 Series Hematology Analyzers
Brand
Beckman Coulter Inc
UPC
Part number -6605632, No lot number applies, all serial numbers apply.

Units Affected

132