Recalls / —

—#25194

Product

COULTER LH 700 Series Hematology Analyzers

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

Affected lot / code info

Part number -6605632, No lot number applies, all serial numbers apply.

Why it was recalled

Software.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 South Kraemer Blvd W, 337, Brea, California 92822

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2002-11-08

Posted by FDA

2003-01-09

Terminated

2003-07-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25194. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.