Kaluza C Flow Cytometry Software Versions: 1 — Class II medical device recall Z-2241-2021
Terminated recall by Beckman Coulter, Inc., reported 2021-08-18, distributed nationwide. Software anomalies that may lead to the generation of erroneous results.
| Recall number | Z-2241-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Miami, FL, United States |
| Recall initiated | 2021-06-23 |
| Classified | 2021-08-11 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2026-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BO, BR, CA, CH, CN, CZ, DE, DK, EC, EG, FR, GB, GR, HK, HU, IL, IN, IT, KE, KR, KW, LT, MX, MY, NL, NO, NZ, PA, PE, PL, PT, SA, SE, SK, TH, TN, TW, UA, VN, ZA |
| Reason classes | software |
Product
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpetual Educational License C10579 - Kaluza C Single User 1-year Educational License C10580 - Kaluza C 10 User Network Educational License C10581 - Kaluza C 5 User Network Educational License and C21166 - Kaluza C Program DVD v1.0
Reason for recall
Software anomalies that may lead to the generation of erroneous results.
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-2241-2021. 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.