Recall Z-1759-2010

Reason for recall

The recall was initiated after Beckman Coulter confirmed reports of potential dilution of reagent vials loaded onto the Preppies or PrepPlus 2 systems. Affected systems have a syringe pump with part number A46748 (see illustrations below) which cause the probe to prematurely dispense Isoflow prior to arriving at the wash station. This condition only occurs with worklist panels which include both

FDA-determined cause: Other

Action taken

A Product Corrective Action (PCA) letter with attached PCA Response Form was sent on the week of January 25, 2010 to all customers who purchased the pipetting and diluting system: COULTER PrepPlus, or COULTER PrepPlus 2. The letter provides the customers with an explanation of the problem identified and an instruction on proper placing antibody reagent when using a worklist panel which involves both blood specimens and antibody reagents. Customers were also instructed to complete and return the PCA Response Form in addition to sharing the information contained in the PCA with their laboratory staff. If consignees had any questions they were told to contact their local Beckman Coulter Representative. Questions can be directed to the company's Customer Service office at (800) 526-7694.