—#32870

Product

Coulter AcT 5diff Autoloader (AL) Hematology Analyzer

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K030291
Affected lot / code info: All software versions (1.00 & 1.20)

Why it was recalled

Software anomaly causes sample results to be not credible, reported as '0' or left blank. The next sample will also be incorrectly reported for the same parameter.

Root cause (FDA determination)

Other

Action the firm took

Firm sent recall letter on or about April 20, 2004 informing users of the issue. Firm will implement a software solution in the near future.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2004-04-20
Posted by FDA: 2004-07-20
Terminated: 2005-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #32870. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.