Roche Diagnostics Operations, Inc. recalls Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS I…

Recall date

September 27, 2016

Source

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

Recall number

Z-0387-2017

FDA classification

Class II

Brand / firm

Roche Diagnostics Operations, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run restarts. If a used cuvette is used again result of the test(s) will be erroneous. These erroneous results may not be flagged. Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the parameter.

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 COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.