Recalls / —

—#32664

Product

Coulter LH750 Hematology Analyzer. Part Number 6605632.

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K011342

Affected lot / code info

Software versions 2A2 and 2B1.

Why it was recalled

If a customer enters a dilution factor for Sample B prior to the results from Sample A being transfered to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A's results once they are received at the workstation.

Root cause (FDA determination)

Other

Action the firm took

A Product Corrective Action Letter was mailed to all customers who currently have the instrument in thier lab. The letter includes a description of what conditions need to be met for the error to occur and the proper steps to prevent the issue from occuring. The letter was sent by US Mail on March 31, 2004.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2004-03-31

Posted by FDA

2004-07-20

Terminated

2012-04-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #32664. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.