FDA Device recall Z-2035-2017
AQUIOS CL Flow Cytometer, Ref no
- FDA Device
- Class II
- terminated
- Published 2017-05-10
On 2017-05-10 the FDA classified a Class II recall of AQUIOS CL Flow Cytometer, Ref no by Beckman Coulter, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2035-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-03 |
| Published | 2017-05-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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).
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.
Identifiers
| code_info | All |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2035-2017%22
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