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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 Cytometersee related information
Date Initiated by FirmOctober 02, 2017
Create DateOctober 11, 2018
Recall Status1 Terminated 3 on May 08, 2019
Recall NumberZ-0091-2018
Recall Event ID 78256
510(K)NumberK141932 
Product Classification Flow cytometric reagents and accessories. - Product Code OYE
ProductAQUIOS 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).
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information ContactAruna 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
ActionBeckman 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 Commerce268 units
DistributionWorldwide 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 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.
510(K) Database510(K)s with Product Code = OYE
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