FDAFDA · Food and drugs·Recall number Z-0793-2013
OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
Published February 13, 2013 · Recall initiated: December 21, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Hitachi Chemical Diagnostics Inc
- Distributor
- Worldwide Distribution - France only
- Lot
- Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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