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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Event Detail

Event ID 63134
Product Type Devices
Status Terminated
Recalling Firm Beckman Coulter Inc.
City Brea
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-01-20
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - US Nationwide and the countries of: Australia, Botswana, Canada, France, Germany, Japan, Malawi and Sweden.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. All Serial Numbers Class II 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. 36 units total (15 units in the US) Z-0002-2013