AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is… — Class II medical device recall Z-3135-2017
Terminated recall by Beckman Coulter Inc., reported 2017-09-27, distributed nationwide. Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can r
| Recall number | Z-3135-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-08-21 |
| Classified | 2017-09-19 |
| Reported by FDA | 2017-09-27 |
| Terminated | 2023-09-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, GH, IL, IT, MY, PA, PK, PL, PT, RO, SE, TR, ZA |
| Reason classes | software |
| Serial numbers | AY20032, AY47063, AY47071, AY51072, AY51075, AZ12030, AZ12033, AZ15038, AZ15044, AZ19046, AZ19047, AZ19052, AZ20057, AZ23058, AZ25065, AZ25068, AZ25070, AZ32071, AZ45080, BA01002, BA01007, BA01010, BA05011, BA05015, BA15023 and 9 more |
Product
AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
Reason for recall
Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.
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-3135-2017. 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.