FDA Device recall Z-0793-2013
OPTIGEN Food 30
- FDA Device
- Class III
- terminated
- Published 2013-02-13
On 2013-02-13 the FDA classified a Class III recall of OPTIGEN Food 30 by Hitachi Chemical Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0793-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-12-21 |
| Published | 2013-02-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hitachi Chemical Diagnostics |
| Distribution | n/a |
Product
OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
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.
Identifiers
| code_info | Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0793-2013%22
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