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U.S. Department of Health and Human Services

Class 3 Device Recall OPTIGEN Food 30

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  Class 3 Device Recall OPTIGEN Food 30 see related information
Date Initiated by Firm December 21, 2012
Date Posted February 07, 2013
Recall Status1 Terminated 3 on May 16, 2013
Recall Number Z-0793-2013
Recall Event ID 64132
510(K)Number K051677  
Product Classification System, test, radioallergosorbent (rast) immunological - Product Code DHB
Product OPTIGEN Food 30; Catalog number: 85035. For allergen testing.

Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA.
Distributed by Theridiag, Cedex, France
Code Information Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.
Recalling Firm/
Manufacturer		 Hitachi Chemical Diagnostics Inc
630 Clyde Ct
Mountain View CA 94043-2239
For Additional Information Contact Lisa Charter
650-961-5501
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DHB and Original Applicant = HITACHI CHEMICAL DIAGNOSTICS, INC.
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