AQUIOS CL Flow Cytometer — Class II medical device recall Z-2035-2017
Terminated recall by Beckman Coulter Inc., reported 2017-05-10, distributed nationwide. Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System softwar
| Recall number | Z-2035-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-04-03 |
| Classified | 2017-05-04 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2017-08-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CL, CZ, DE, DK, ES, FI, FR, GB, GH, IL, IT, MY, NL, PA, PK, PL, PT, RO, SE, SK, TR, ZA |
| Reason classes | software |
| Model numbers | B30166 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2035-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.