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U.S. Department of Health and Human Services

Class 2 Device Recall AQUIOS Lyse Reagent Kit

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  Class 2 Device Recall AQUIOS Lyse Reagent Kit see related information
Date Initiated by Firm October 19, 2016
Date Posted November 21, 2016
Recall Status1 Terminated 3 on February 24, 2017
Recall Number Z-0648-2017
Recall Event ID 75503
510(K)Number K141932  
Product Classification Flow cytometric reagents and accessories. - Product Code OYE
Product AQUIOS Lyse Reagent Kit, Catalog No. B23538

Product Usage:
AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.
Code Information 6040014K 6040015K
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL when running the AQUIOS Tetra application. The issue could lead to an increase in the number of samples requiring review and re-runs with a potential delay to the reporting of results. Depending on the specimen age, a new blood specimen may be required.
FDA Determined
Cause 2		 Under Investigation by firm
Action Beckman Coulter sent an Urgent Medical Device Recall letter dated October 19, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact our Customer Support Center http://www.beckmancoulter.com/customersupport/support; 1-800-369-0333 in the US and Canada; outside the US and Canada contact local Beckman Coulter Representative.
Quantity in Commerce 2367 units total (207 units in US)
Distribution Worldwide Distribution - US Nationwide and the countries of Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Italy, Malaysia, Netherlands, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom and Zambia
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 = OYE and Original Applicant = BECKMAN COULTER, INC.
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