FDA Device recall Z-1341-2018
AQUIOS CL Flow Cytometer System, Catalog #B30166
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of AQUIOS CL Flow Cytometer System, Catalog #B30166 by Beckman Coulter, citing the device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1341-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-29 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.
Reason
The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification.
Identifiers
| code_info | All software versions. |
|---|
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-1341-2018%22
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