FDAJuly 14, 2017device

Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light micros...

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

The hazard

A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.

What to do

FDA enforcement status: Terminated

Brands named

leica biosystems richmondleicaleica 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 →