—#90203

Product

COULTER PrepPlus 2, Part Number: 378600

FDA product code: JQW — Station, Pipetting And Diluting, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: All Serial Numbers are affected.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Domestically and Canada.

Timeline

Recall initiated: 2010-01-21
Posted by FDA: 2010-06-04
Terminated: 2012-04-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90203. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.