iQ200 Series Urine Microscopy Analyzer — Class II medical device recall Z-0914-2020
Terminated recall by Beckman Coulter Inc., reported 2020-02-05. Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID)
| Recall number | Z-0914-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2019-10-28 |
| Classified | 2020-01-29 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2026-04-01 |
| Quantity | 6,601 devices |
| UPC / GTIN / UDI-DI | 10837461001256, 10837461001300, 10837461001317, 10837461001355 |
| Model numbers | 3320, 3340, 700, 700-3300RFB, 700-3320RFB, 700-3322, 700-3322RFB, 700-3325, 700-3326, 700-3345, 700-3347, 700-3370, 700-3375, B48999, C10683, C10684, IQ200 |
Product
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.
Reason for recall
Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).
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-0914-2020. 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.