Z-1643-2018Class II

BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719...

Name: Z-1643-2018 BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719...
Creator: Beckman Coulter Inc.
Published: 2018-03-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-03-02 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079... on 2018-03-02. FDA classified it as Class II and gives the reason as "Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings can result in the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1643-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-02
Posted: 2018-05-04
Terminated: 2023-07-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: 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 an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterade, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer. The measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver finction. Tests performed using the iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
Product code: KQO Automated Urinalysis System
Reason for recall: Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations. 2. The installation of colors different from those stated in the Instructions for Use (Colorless, Straw, Yellow, Amber, Red, Blue) for output settings will result in incorrect reporting of colors. For example, if Green is the color choice for the output setting instead of Blue, Green will be reported.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Beckman Coulter sent an Urgent Field Safety Notice letter dated February 22, 2018 to the customers. The letter identified the affected product, problem and actions to be taken. Beckman Coulter will schedule a site visit to verify the reporting units of measurement for the laboratory within 90 days of this recall initiation. For questions call 800-854-3633.
Quantity in commerce: 2225 units
Distribution: Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Malaysia, Singapore, Taiwan, Thailand, Turkey
Product codes and lots: All Fielded Serial Numbers with North American Configuration settings

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1643-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1643-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code KQO

K101852Class IChem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I / cleared 2011-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)