FDA Medical Device Recalls (openFDA)
Hitachi Chemical Diagnostics Inc: OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
- Recall number
- Z-0793-2013
- Recalling firm
- Hitachi Chemical Diagnostics Inc
- Product
- OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
- Status
- Terminated
- Initiated
- 2012-12-21
- Posted
- 2013-02-07
- Terminated
- 2013-05-16
- 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.
- 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
- 20 kits
- Distribution
- Worldwide Distribution - France only
- Lot, serial or model codes
- Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.
- 510(k) numbers
- ["K051677"]
- PMA numbers
- not on file
- Product code
- DHB
- Firm FEI
- 2936856
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28