iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model… — Class II medical device recall Z-1366-2018
Terminated recall by Beckman Coulter Inc., reported 2018-04-18, distributed nationwide. iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels ca
| Recall number | Z-1366-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-11-10 |
| Classified | 2018-04-12 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2022-12-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BH, BM, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DZ, EC, ES, FR, GB, GR, GT, HK, HR, HU, ID, IL, IN, IQ, IT, JP, KE, KR, KW, LB, LT, MA, MX, MY, NG, NL, NZ, PA, PE, PH, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SK, TH, TN, TR, TW, UY, VE, VN, ZA |
| Quantity | 4,350 units |
| Reason classes | labeling |
| Model numbers | 800-3042, 800-3043, 800-3044, 800-3046, 800-3047, 800-3049, 800-3050, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3938, 800-3950, 800-3951, 800-7101, 800-7102, 800-7157 and 5 more |
Product
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
Reason for recall
iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria.
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-1366-2018. 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.