1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC… — Class I medical device recall Z-0471-2019
Terminated recall by Beckman Coulter Inc., reported 2018-11-28, distributed nationwide. A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifti
| Recall number | Z-0471-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-01-12 |
| Classified | 2018-11-20 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2024-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BB, BD, BE, BG, BH, BR, BS, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EG, ES, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JP, KE, KR, KW, LB, LK, LV, MA, MX, MY, NG, NL, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 3,115 |
Product
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
Reason for recall
A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application.
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-0471-2019. 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.