BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer — Class II medical device recall Z-1362-2018
Terminated recall by Beckman Coulter Inc., reported 2018-04-18. Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high
| Recall number | Z-1362-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-03-02 |
| Classified | 2018-04-11 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2023-07-06 |
| Quantity | 5,247 units |
| Reason classes | software |
| Model numbers | 700-3320, 700-3322, 700-3325, 700-3345, 700-3347, 700-3370, 700-3375, C10683, C10684 |
Product
BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
Reason for recall
Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting per low-power field (/LPF)* or *per microliter. This may occur during initial method validation or if settings are altered after the initial validation.
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-1362-2018. 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.