iChem VELOCITY Automated Urine Chemistry — Class II medical device recall Z-1067-2016
Terminated recall by Beckman Coulter Inc., reported 2016-03-16, distributed in PR. Iris International noted loose or missing analyte pads found in several locations (strip vial, strip provider
| Recall number | Z-1067-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2016-01-13 |
| Classified | 2016-03-07 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2016-08-29 |
| Distributed | PR |
| Countries outside the US | AR, AT, AU, BD, BM, BR, CA, CH, CL, CN, CZ, DE, EC, ES, FR, GR, HK, HR, HU, ID, IL, IN, IT, JO, JP, KR, KW, LB, LT, MX, MY, NG, NL, NZ, OM, PA, PE, PH, PL, PT, PY, QA, RO, RS, SA, SG, SK, TH, TR, TW, VE, ZA |
| Model numbers | 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7212, 800-7212-001, 800-7713, 800-7714, 800-7719, 800-7720 |
Product
iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001
Reason for recall
Iris International noted loose or missing analyte pads found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the iChemVELOCITY System.
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-1067-2016. 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.