iChemVELOCITY Automated Urine Chemistry Catalog No — Class II medical device recall Z-2441-2015
Terminated recall by Iris Diagnostics, reported 2015-09-02, distributed nationwide. Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stab
| Recall number | Z-2441-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iris Diagnostics, Chatsworth, CA, United States |
| Recall initiated | 2015-07-15 |
| Classified | 2015-08-21 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2016-05-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BH, BO, BR, CA, CH, CL, CN, CO, CZ, DE, EC, ES, FR, GB, GR, HK, HR, HU, IL, IN, IT, JO, KR, KW, LB, LU, MA, MX, MY, NL, NZ, OM, PA, PE, PH, PL, PT, PY, QA, RO, RS, SA, SG, SK, TH, TR, TW, VE, ZA |
| Quantity | 2,448 units |
| Reason classes | labeling, specification failure |
| Model numbers | 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 |
Product
iChemVELOCITY 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. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.
Reason for recall
Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling.
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-2441-2015. 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.