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U.S. Department of Health and Human Services

Class 2 Device Recall Coulter PrepPlus 2

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 Class 2 Recall
Coulter PrepPlus 2
see related information
Date Posted October 07, 2011
Recall Status1 Terminated on April 04, 2012
Recall Number Z-0028-2012
Recall Event ID 59535
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
Product Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 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 Serial Numbers: 1001008698, 1001008699, and 10018700.
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
The recall was initiated because Beckman Coulter has confirmed an issue with the Coulter PrePlus 2. The reagent level sensing is impaired and will give no warning when a reagent vial is low or out of reagent. Due to the size difference in the vertical mounts, the reagent rack is not aligned optimally for the probe to aspirate or level sense the antibody. This misalignment yields impaired reagen
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action Beckman Coulter initiated an URGENT: PRODUCT CORRECTIVE ACTION (PCA) letter dated August 24, 2010, with attached PCA Response Form to all affected customers who purchased the Coulter PrepPlus 2. The letter provided the customers with an explanation of the problem identified and an action to be taken. The customers were instructed to not use the PrepPlus2 until their Beckman Coulter representative corrects the problem. A review of all results generated from samples prepared from the system should be conducted. Any unexpected dim fluorescence and/or decreased number stained cells should be evaluated for re-analysis, including preparing a new sample. Customers were also instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding this PCA, were instructed to call Beckman Coulter Customer service at (800) 526-7694. Outside of USA, customers were instructed to contact their local Beckman Coulter Representative.
Quantity in Commerce 391 units total (193 in US)
Distribution Worldwide distribution.
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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