OPTIGEN Food 30 — Class III medical device recall Z-0793-2013
Terminated recall by Hitachi Chemical Diagnostics Inc, reported 2013-02-13. There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fi
| Recall number | Z-0793-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi Chemical Diagnostics Inc, Mountain View, CA, United States |
| Recall initiated | 2012-12-21 |
| Classified | 2013-02-07 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2013-05-16 |
| Countries outside the US | FR |
| Quantity | 20 kits |
| Lot numbers | 42K283626 |
| Model numbers | 85035 |
| Expiration dates | 2013-05-31 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0793-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.