FDA-Device2014-07-30Class II
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Biogenex Laboratories, Inc.
Hazard
Product was distributed without 510(k) approval.
Sold states
Brazil and Ecuador. No US distribution
Affected count
4 kits
Manufactured in
49026 Milmont Dr, Fremont, CA, United States
Products
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2113-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief