Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

OPTIGEN Food 30 Recalled by Hitachi Chemical Diagnostics Inc Due to There is no evidence that a visual inspection...

Date: December 21, 2012
Company: Hitachi Chemical Diagnostics Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hitachi Chemical Diagnostics Inc directly.

Affected Products

OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France

Quantity: 20 kits

Why Was This 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.

Where Was This Sold?

Worldwide Distribution - France only

About Hitachi Chemical Diagnostics Inc

Hitachi Chemical Diagnostics Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report