Roche Diagnostics Operations product recalled over hepatitis A risk

Recall date

July 15, 2016

Source

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

Official notice title

Roche Diagnostics Operations, Inc. recalls cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a compute…

Recall number

Z-0110-2017

FDA classification

Class II

Brand / firm

Roche Diagnostics Operations, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

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

What was recalled

cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and decapping of sample tubes, liquid level detection (optional) and sample quality detection (optional), as well as recapping of sample tubes (optional).