| Class 2 Device Recall AQUIOS CL Flow Cytometer Software | |
Date Initiated by Firm | April 03, 2017 |
Date Posted | April 17, 2017 |
Recall Status1 |
Terminated 3 on August 07, 2017 |
Recall Number | Z-2035-2017 |
Recall Event ID |
76961 |
510(K)Number | K141932 |
Product Classification |
Flow cytometric reagents and accessories. - Product Code OYE
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Product | AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1
Product Usage:
The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV). |
Code Information |
All |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
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Manufacturer Reason for Recall | Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files. |
FDA Determined Cause 2 | Other |
Action | An Urgent Medical Device Recall letter was sent on 4/3/17 to inform customers that area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files. The letter informs the customers of the impact, action, and resolution. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Customer Support Center via website, http://www.beckmancoulter.com/customersupport/support, Via phone, call 1-800-369-0333 in the US. Customers outside the US are instructed to contact their local Beckman Coulter Representative. |
Quantity in Commerce | 188 units total (24 units in US) |
Distribution | Worldwide - US Nationwide in the countries of: Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia, Netherlands, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Kingdom and Zambia |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = OYE
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