Roche Diagnostics Operations product recalled over laceration hazard

Recall date

July 15, 2016

Source

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

Official notice title

Roche Diagnostics Operations, Inc. recalls cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800…

Recall number

Z-0107-2017

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 p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in diagnostic laboratories.