Product Corrective Action: PK7300 Reagent Probes

DATE NOTIFICATION INITIATED:

December 2, 2010

PRODUCT

PK7300 Reagent Probes

MANUFACTURER:

Beckman Coulter, Inc.
Brea, California

REASON:

Beckman Coulter has confirmed an issue with the PK7300 Automated Microplate System. Unused reagent probes may drip water and depending upon the position, drip or splatter onto the microplate. If this water were to drip or splatter into wells used for testing it could potentially affect results. Erroneous test results are, however, not expected, provided that plate review was performed and action was taken if water drips or splatters were observed on the plates or hemolysis observed in the test wells. Customers are asked to keep their notification with the PK7300 Users Guide.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.