UA WIN 10 Kit — Class II medical device recall Z-1599-2023
Ongoing recall by Beckman Coulter, Inc., reported 2023-05-24. Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sper
| Recall number | Z-1599-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Miami, FL, United States |
| Recall initiated | 2023-04-05 |
| Classified | 2023-05-17 |
| Reported by FDA | 2023-05-24 |
| Quantity | 306 units |
| UPC / GTIN / UDI-DI | 15099590735982 |
| Model numbers | C52900 |
Product
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
Reason for recall
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.
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-1599-2023. 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.