Optigen Food 30 recall
OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
Why was Optigen Food 30 recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.
- Product
- OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
- Recalling firm
- Hitachi Chemical Diagnostics Inc
- Quantity
- 20 kits
- Distribution
- Worldwide Distribution - France only
- Recall date
- February 13, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)