Recalls / —

—#26177

Product

LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K011342

Affected lot / code info

All instruments with version 2A or higher.

Why it was recalled

Incorrect Hemoglobin result can be reported with software version 2A and higher.

Root cause (FDA determination)

Other

Action the firm took

Customers were contacted by telephone and mail from 1/27/03 to 2/3/2003. Notice included modified operating instructions. A software fix is being developed and will be installed by Beckman personnel.

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

2002-12-27

Posted by FDA

2003-03-21

Terminated

2003-07-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #26177. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.