FDAJuly 15, 2016device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnostics operationsrocheroche diagnostics

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →