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).
FDA Recall Z-2035-2017 · Posted 2017-04-17
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeOYE
Date Initiated2017-04-03
Date Terminated2017-08-07
Product Quantity188 units total (24 units in US)
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.