iQ200 Series Urine Microscopy Analyzers — Class II medical device recall Z-0785-2024
Ongoing recall by Beckman Coulter, Inc., reported 2024-01-31. Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste
| Recall number | Z-0785-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Miami, FL, United States |
| Recall initiated | 2023-12-19 |
| Classified | 2024-01-25 |
| Reported by FDA | 2024-01-31 |
| Countries outside the US | AU, BR, CA, CN, DE, ES, FR, GB, GH, IE, IL, IN, IT, LB, LT, MX, PA, QA, RO, SA, TW |
| Quantity | 112 units |
| UPC / GTIN / UDI-DI | 10837461001188, 10837461001256, 10837461001300, 10837461001317, 10837461001324, 10837461001355, 15099590695484, 15099590697129 |
| Serial numbers | IQ200 |
Product
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684
Reason for recall
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate 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-0785-2024. 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.