—#67307

Product

Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K030828
Affected lot / code info: All Software Versions

Why it was recalled

Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.

Root cause (FDA determination)

Software design

Action the firm took

A Product Corrective Action (PCA) letter, dated August 16, 2007, informed the customers that the User documentation and Online Help for the FC500 with Data Innovations lnstrument Manager are not clear enough to avoid potential demographic and sample type mismatches under certain conditions. The letter asks the customers to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They are also to review all sample identification, demographics, data and results before reporting results out. A response form is included. Questions and concerns regarding the notification should be directed to Beckman Coulter Customer Service at 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: 2007-08-20
Posted by FDA: 2008-08-08
Terminated: 2012-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67307. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.