iChemVELOCITY Urine Chemistry System — Class II medical device recall Z-1384-2017
Terminated recall by Beckman Coulter Inc., reported 2017-03-08, distributed nationwide. The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient
| Recall number | Z-1384-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-01-30 |
| Classified | 2017-03-01 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2017-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BO, BR, CA, CH, CL, CN, CZ, DE, EC, ES, FR, GR, HK, HR, HU, ID, IL, IN, IT, JO, JP, KR, KW, LB, MX, MY, NG, NL, NZ, OM, PA, PE, PH, PL, PT, PY, QA, RO, RS, SA, SG, SK, TH, TR, TW, VE, ZA |
| Serial numbers | V01003, V01008, V01036, V01037, V01038, V01042, V01043, V01044, V01046, V01048, V01054, V01055, V01056, V01057, V01058, V01059, V01061, V01064, V01070, V01071, V01072, V01073, V01074, V01075, V01076 and 475 more |
| Model numbers | 800-3061, 800-3530, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-7167, 800-7719, 800-7720 |
Product
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips
Reason for recall
The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.
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-1384-2017. 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.