—#112657

Product

COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

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

Why it was recalled

The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may experience intermittant reagent level sense failures where the instrument may not produce a warning that a reagent vial is low or out of reagent.

Root cause (FDA determination)

Device Design

Action the firm took

Beckman Coulter sent an Urgent Product Correction letter dated January 20, 2012 to all their customers who purchased the affected product. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were instructed to complete and return the Response Form with in 10 days. Customers with questions regarding the PCA letter were instructed to contact Beckman Coulter Service at (800) 526-7694 in the US and Canada or contact their local Beckman Coulter Representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, M/S A2.SW.01, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Australia, Botswana, Canada, France, Germany, Japan, Malawi and Sweden.

Timeline

Recall initiated: 2012-01-20
Posted by FDA: 2012-10-01
Terminated: 2012-10-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112657. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.