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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 PrepPlus see related information
Date Initiated by Firm May 22, 2017
Create Date July 07, 2017
Recall Status1 Terminated 3 on March 31, 2021
Recall Number Z-2689-2017
Recall Event ID 77362
510(K)Number K130253  
Product Classification Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis - Product Code PER
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 currently in the field
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
FDA Determined
Cause 2		 Software design
Action The recalling firm initiated their recall by letter disseminated via email on 05/22/2017. The letter requested the following actions be taken: 1. Insert an empty daughter tube in place of a patient sample as the first tube in the carousel that is programmed for the addition of Flow-Count Fluorospheres.  2. Refer to the COULTER PrepPlus Operators Guide / PrepPlus 2 Instructions for Use (IFU) for instructions on adding Flow-Count Fluorospheres to daughter tubes. 3. Review all results following the flow cytometer data review instructions referenced in the associated IFU. Beckman Coulter also requested the consignee share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If the consignee forwarded any of the affected product(s) listed above to another laboratory, They were asked to provide them a copy of the letter.
Quantity in Commerce 43 units
Distribution Worldwide Distribution
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = PER and Original Applicant = BECKMAN COULTER, INC.
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