Device product
OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
Z-0793-2013
Product summary
- Event
- Event 64132
- Status
- Terminated
- Classification
- Class III
- Quantity
- 20 kits
- Official record key
device-enforcement:Z-0793-2013
Official wording
Reason: 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.
Code information: Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.
Distribution pattern: Worldwide Distribution - France only
Derived failure modes
-
Unknown
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.