—#40707

Product

Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
Affected lot / code info: Versions 1.1 and 2.0

Why it was recalled

Software anomally. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results.

Root cause (FDA determination)

Other

Action the firm took

Letters issued to users on July 13, 2005 which also included modified operating instructions, and response cards.

Recalling firm

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

Distribution

Distribution pattern: USA

Timeline

Recall initiated: 2005-07-06
Posted by FDA: 2005-08-17
Terminated: 2012-04-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40707. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.