—#163764

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.

FDA product code: LJX — Test, Urine Leukocyte
Device class: Class 1
Medical specialty: Hematology
510(k) numbers: K101852
Affected lot / code info: Lot #7212154 A

Why it was recalled

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.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution and US Nationwide Distribution

Timeline

Recall initiated: 2017-12-04
Terminated: 2023-05-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163764. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.