Roche Diagnostics Corporation recalls Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is…

Recall date

September 24, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0301-2019

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

US Nationwide Distribution

Why it was recalled

Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA test strips were higher than what is listed in the test strip method sheets may lead to false negative results for the affected parameters

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine test strips for various urine analytes.: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood