Hitachi Chemical Diagnostics Inc recalls OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountai

Recalled February 13, 2013 · FDA recall Z-0793-2013 · Hitachi Chemical Diagnostics

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. · FDA Class III

Units

20 kits

Sold at

Worldwide Distribution - France only

Description

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.

Product

OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France

Manufacturer(s)

Hitachi Chemical Diagnostics Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →