—#93637

Product

CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology Analyzer, Manufactured by Abbott Laboratories, Santa Clara, CA

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K051215
Affected lot / code info: List 08H00-01, 08H00-03, PCB Assembly part number 8960167101

Why it was recalled

Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results.

Root cause (FDA determination)

Other

Action the firm took

Abbott Diagnostics Division of Santa Clara, CA initiated a field correction of the CELL-DYN Sapphire Probe Detector Assembly used on the CELL-DYN Sapphire Hemotology Analyzer, on April 5, 2010. The correction is being addressed through field service representatives and a mandatory Technical Service Bulletin (TSB). The TSB requires inspection, testing, and potential replacement of the affected assembly. The firm will not be issuing a seperate notification. For questions regarding this correction please contact (408) 982-4800, or fax (408) 982-4863.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern: Product was distributed to 926 retailers throughout the US and to argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong King, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela.

Timeline

Recall initiated: 2010-04-05
Posted by FDA: 2010-09-14
Terminated: 2011-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93637. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.