Recall Z-2035-2017 ยท OYE Flow Cytometric Reagents And Accessories.
Beckman Coulter Inc.
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).
| Date | Apr 17, 2017 (initiated Apr 3, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 R |
| Quantity | 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, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141932 | AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS Beckman Coulter, Inc., Apr 10, 2015 |