Recall Z-1894-2018— Beckman Coulter Inc.

Name: FDA recall Z-1894-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-29

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2018-03-29, terminated 2019-06-27. It names one FDA 510(k) clearance: K101852. 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..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-29
Terminated: 2019-06-27
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K101852 — CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITIris International Inc., A Division of Iris Iris I·cleared 2011-03-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.