Z-0793-2013Class III

OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics...

Name: Z-0793-2013 OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics...
Creator: Hitachi Chemical Diagnostics Inc
Published: 2012-12-21
License: https://open.fda.gov/license/

Canon Medical Diagnostics USA, Inc. / initiated 2012-12-21 / Terminated / root cause: manufacturing process

FDA source

Hitachi Chemical Diagnostics Inc began a recall of OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex... on 2012-12-21. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0793-2013
Classification: Class III
Status: Terminated
Initiated: 2012-12-21
Posted: 2013-02-07
Terminated: 2013-05-16
Recalling firm: Canon Medical Diagnostics USA, Inc.
Product: OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
Product code: DHB System, Test, Radioallergosorbent (Rast) Immunological
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Hitachi sent an Urgent Product Recall Notification letter dated December 21, 2012, to the affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was instructed to discontinue distribution and destroy any remaining inventory of the affected product at their location per their local waste ordinances, determine if any of their customers are using or have inventory of the affected product, rquest that their customers review all patient results reported with the use of the affectted product. The customer was instructed to tell their customers to discontinue use and destroy any remaining inventory per their local waste ordinances. The customer was instructed to retain a copy of the notification letter for their records. The customer was also instructed to send confirmation of the destruction within 5 days Customers were instructed to complete and return the attached Certificate of Destruction. For questions customers were instructed to contact their local area Customer Service. For questions regarding this recall 650-961-5501.
Quantity in commerce: 20 kits
Distribution: Worldwide Distribution - France only
Product codes and lots: Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0793-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0793-2013	Class III	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-07

Product code DHB

K051677Class IIOptigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc. / cleared 2006-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)