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U.S. Department of Health and Human Services

Class 2 Device Recall COULTER PrepPlus

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 Class 2 Recall
COULTER PrepPlus
see related information
Date Posted October 01, 2012
Recall Status1 Terminated on October 02, 2012
Recall Number Z-0002-2013
Recall Event ID 63134
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
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.
Code Information All Serial Numbers
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
M/S A2.SW.01
Brea, California 92821-6232
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Clair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 36 units total (15 units in the US)
Distribution Worldwide Distribution - US Nationwide and the countries of: Australia, Botswana, Canada, France, Germany, Japan, Malawi and Sweden.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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