FDA Device recall Z-0091-2018
AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland
- FDA Device
- Class II
- terminated
- Published 2017-11-22
On 2017-11-22 the FDA classified a Class II recall of AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland by Beckman Coulter, citing the system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0091-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-02 |
| Published | 2017-11-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, PR, SC, TX, WA |
Product
AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software.
Reason
The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
Identifiers
| code_info | All existing software versions (2.0, 2.0.1, and 2.1). |
|---|
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-0091-2018%22
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