FDA Device recall Z-1894-2018
iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Ca…
- FDA Device
- Class II
- terminated
- Published 2018-05-30
On 2018-05-30 the FDA classified a Class II recall of iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Ca… by Beckman Coulter, citing the Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1894-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-29 |
| Published | 2018-05-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | AL, FL, GA, IA |
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
The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
Identifiers
| code_info | Catalog 700-7176-001 - Serial numbers V04494 and CV04015; Catalog 700-7177-001 - Serial numbers CV04012, CV04013, CV04014, and CV04017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1894-2018%22
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