iChem VELOCITY Automated Urine Chemistry System — Class II medical device recall Z-1894-2018
Terminated recall by Beckman Coulter Inc., reported 2018-05-30, distributed in AL, FL, GA, IA. The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for corr
| Recall number | Z-1894-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-03-29 |
| Classified | 2018-05-18 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2019-06-27 |
| Distributed | AL, FL, GA, IA |
| Quantity | 6 devices |
| Reason classes | packaging |
| Serial numbers | CV04012, CV04013, CV04014, CV04015, CV04017, V04494 |
| Model numbers | 700-7176-001, 700-7177-001 |
Product
iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in a iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems.
Reason for recall
The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
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-1894-2018. 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.