OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemic...
FDA Recall #Z-0793-2013 — Class III — December 21, 2012
Product Description
OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
Reason for Recall
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.
Recalling Firm
Hitachi Chemical Diagnostics Inc — Mountain View, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
20 kits
Distribution
Worldwide Distribution - France only
Code Information
Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated