Z-1894-2018 Class II Terminated
FDA device recall Z-1894-2018 was initiated by Beckman Coulter Inc. on Mar 29, 2018 and is designated Class II. 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. The recall status is terminated (terminated Jun 27, 2019). Affected quantity: 6 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- Mar 29, 2018
- Termination Date
- Jun 27, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 devices
Product Description
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.
Distribution Pattern
US Distribution to states of: AL, IA, GA, and FL.
Code Information
Catalog 700-7176-001 - Serial numbers V04494 and CV04015; Catalog 700-7177-001 - Serial numbers CV04012, CV04013, CV04014, and CV04017.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1894-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026