Recall Z-0793-2013— Hitachi Chemical Diagnostics Inc

Name: FDA recall Z-0793-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-21

Class III · Terminated

Class III FDA medical device recall by Hitachi Chemical Diagnostics Inc, initiated 2012-12-21, terminated 2013-05-16. It names one FDA 510(k) clearance: K051677. 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..

Recalling firm: Hitachi Chemical Diagnostics Inc
Classification: Class III
Status: Terminated
Initiated: 2012-12-21
Terminated: 2013-05-16
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K051677 — OPTIGEN ALLERGEN SPECIFIC IGE ASSAYHitachi Chemical Diagnostics, Inc.·cleared 2006-01-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.