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U.S. Department of Health and Human Services

Class 2 Device Recall AQUIOS CL Flow Cytometer

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  Class 2 Device Recall AQUIOS CL Flow Cytometer see related information
Date Initiated by Firm October 02, 2017
Create Date October 11, 2018
Recall Status1 Terminated 3 on May 08, 2019
Recall Number Z-0091-2018
Recall Event ID 78256
510(K)Number K141932  
Product Classification Flow cytometric reagents and accessories. - Product Code OYE
Product AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland.

The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software.
Code Information All existing software versions (2.0, 2.0.1, and 2.1).
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Aruna Badiga, Ph. D.
305-380-4189
Manufacturer Reason
for Recall		 The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
FDA Determined
Cause 2		 Software design
Action Beckman Coulter sent an Urgent Medical Device Recall letter dated September 28, 2017, and via phone on October 4, 2017. On 11/30/2017, the firm issued an updated letter dated 11/28/2017. The letter informs the customer this letter replaces the instructions in the original notification dated 9/28/2017.
Quantity in Commerce 268 units
Distribution Worldwide Distribution - US Distribution to the states of : AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, SC, TX, and WA, including Puerto Rico and government distribution, and to the countries of : Canada, Angola, Australia, Belgium, Botswana, Brazil, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, Ukraine, 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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