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U.S. Department of Health and Human Services

Class 2 Device Recall COULTER PrepPlus

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 Class 2 Device Recall COULTER PrepPlussee related information
Date Initiated by FirmJanuary 20, 2012
Date PostedOctober 01, 2012
Recall Status1 Terminated 3 on October 02, 2012
Recall NumberZ-0002-2013
Recall Event ID 63134
Product Classification Station, pipetting and diluting, for clinical use - Product Code JQW
ProductCOULTER 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
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
M/S A2.SW.01
Brea CA 92821-6232
For Additional Information ContactClair 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		Device Design
ActionBeckman 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 Commerce36 units total (15 units in the US)
DistributionWorldwide Distribution - US Nationwide and the countries of: Australia, Botswana, Canada, France, Germany, Japan, Malawi and Sweden.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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