Hitachi Chemical Diagnostics Inc: Medical Device Recall in 2013 - (Recall #: Z-0793-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: December 21, 2012

Date Posted: February 13, 2013

Recall Number: Z-0793-2013

Event ID: 64132

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.

Status: Terminated

Product Quantity: 20 kits

Code Information:

Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.

Distribution Pattern:

Worldwide Distribution - France only

Voluntary or Mandated:

Voluntary: Firm initiated