—#67141

Product

Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 15 network user with Romlock, Automated differential cell counter; Part Number 722595; Beckman Coulter; Miami, FL 33196.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
Affected lot / code info: Part Number 722595

Why it was recalled

Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in the panel.

Root cause (FDA determination)

Software design

Action the firm took

Consignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution including USA and country of Canada.

Timeline

Recall initiated: 2007-05-04
Posted by FDA: 2008-07-11
Terminated: 2011-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67141. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.