Device 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.
Z-1894-2018
Product summary
- Event
- Event 79895
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 devices
- Official record key
device-enforcement:Z-1894-2018
Official wording
Reason: The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
Code information: Catalog 700-7176-001 - Serial numbers V04494 and CV04015; Catalog 700-7177-001 - Serial numbers CV04012, CV04013, CV04014, and CV04017.
Distribution pattern: US Distribution to states of: AL, IA, GA, and FL.
Derived failure modes
-
Unknown
The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.