AllClear
PricingSign in
FDADecember 10, 2018device

Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

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

The hazard

The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images.

What to do

FDA enforcement status: Terminated

Brands named

leica biosystems imagingleicaleica biosystems

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 →