FDA recall Z-2360-2018

Product

Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S

Reason for recall

Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.

Distribution

CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany

Key facts

Status

Terminated

Initiation date

2018-04-24

Report date

2018-07-11

Termination date

2020-07-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pacheco, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2360-2018