FDA-Device2013-02-13Class III
OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
Hitachi Chemical Diagnostics Inc
Hazard
There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results.
Sold states
Worldwide Distribution - France only
Affected count
20 kits
Manufactured in
630 Clyde Ct, N/A, Mountain View, CA, United States
Products
OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0793-2013Don'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