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

FDA device recall Z-0793-2013 · posted 2013-02-07 · Terminated

Recall details

Recalling firm

Hitachi Chemical Diagnostics Inc

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

DHB

Quantity affected

20 kits

Distribution

Worldwide Distribution - France only

Date initiated

2012-12-21

Date posted

2013-02-07

Date terminated

2013-05-16

Location

Mountain View, CA

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