Z-0793-2013 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2013
- Initiation Date
- December 21, 2012
- Termination Date
- May 16, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 kits
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.
Distribution Pattern
Worldwide Distribution - France only
Code Information
Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.