Kaluza C Flow Cytometry Software — Class II medical device recall Z-1982-2019
Terminated recall by Beckman Coulter Inc., reported 2019-07-24, distributed in CA, NY. Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issu
| Recall number | Z-1982-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-09-17 |
| Classified | 2019-07-17 |
| Reported by FDA | 2019-07-24 |
| Distributed | CA, NY |
| Countries outside the US | CH, DE, GB |
| Quantity | 41 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 15099590705084, 15099590705091, 15099590705107, 15099590705114, 15099590705121, 15099590705138, 15099590705145, 15099590705152, 15099590705169 |
Product
Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year educational License (G) Kaluza C 10 User Network Educational License (H) Kaluza C 5 User Network Educational License (I) Kaluza C Flow Cytometry Software
Reason for recall
Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting 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-1982-2019. 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.