AQUIOS CL Flow Cytometer System — Class II medical device recall Z-1341-2018
Terminated recall by Beckman Coulter Inc., reported 2018-04-18, distributed nationwide. The device may process the same sample with two different sample IDs and sample information while using the si
| Recall number | Z-1341-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-01-29 |
| Classified | 2018-04-10 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2019-06-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, GH, HK, IL, IN, IT, JP, KE, MX, MY, NL, NO, NZ, PA, PK, PL, PT, RO, SE, SK, TR, TW, UA, ZA |
| Quantity | 288 devices |
| Model numbers | B30166 |
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 for recall
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.
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-1341-2018. 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.