iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select — Class II medical device recall Z-1596-2023
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-1596-2023 |
|---|---|
| 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 | 1,068 units |
| UPC / GTIN / UDI-DI | 10837461001256, 10837461001300, 10837461001317, 10837461001355, 15099590695484, 15099590697129 |
| Model numbers | 10837461001317, 700-3325, 700-3345, 700-3347, 700-3375, C10683, C10684 |
Product
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
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-1596-2023. 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.