Medical Device Recall: Z-0002-2013

FDA Recalls dataset · Firm: Beckman Coulter Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2012-01-20 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0002-2013.

Recall Res Number
Z-0002-2013
Recalling Firm / Manufacturer
Beckman Coulter Inc.
FEI Number
2050012
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2012-01-20
Date Posted
2012-10-01
Date Terminated
2012-10-02
Product Code
JQW
Event Number
63134
Product Quantity
36 units total (15 units in the US)
Product Description 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.
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.
Action Details 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.
Distribution Pattern Worldwide Distribution - US Nationwide and the countries of: Australia, Botswana, Canada, France, Germany, Japan, Malawi and Sweden.
Code Information / Serial Numbers All Serial Numbers

Related Establishments / Registrations

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