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Terminated

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 Recall Z-0002-2013 · Posted 2012-10-01

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJQW
Date Initiated2012-01-20
Date Terminated2012-10-02
Product Quantity36 units total (15 units in the US)

Reason for Recall

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.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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