Z-1893-2018Class II

iChem VELOCITY Urine Chemistry Strips, REF 800-7212

Name: Z-1893-2018 iChem VELOCITY Urine Chemistry Strips, REF 800-7212
Creator: Beckman Coulter Inc.
Published: 2017-12-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-12-04 / Terminated

FDA source

Beckman Coulter Inc. began a recall of iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to... on 2017-12-04. FDA classified it as Class II and gives the reason as "A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure for leukocytes and may generate false...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1893-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-04
Posted: 2018-05-18
Terminated: 2023-05-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY 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 esterase, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChem VELOCITY strips are intended for use with the iCHEM VELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChem VELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iCHEM VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
Product code: LJX Test, Urine Leukocyte
Reason for recall: A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure for leukocytes and may generate false negative erroneous results for leukocytes.
FDA root cause: Mixed-up of materials/components
Action: The firm initiated the recall by letter on 12/04/2017. The letter identified the affected product, problem and the actions to be taken. The firm requested destruction of the recalled product.
Quantity in commerce: 14340 units
Distribution: Worldwide Distribution and US Nationwide Distribution
Product codes and lots: Lot #7212154 A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1893-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1893-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-17

Product code LJX

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)