Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use
FDA device recall Z-1093-2014 · posted 2014-02-26 · Terminated
Recall details
- Recalling firm
- Dako North America Inc.
- Reason for recall
- Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
- Action taken
- Dako sent a Recall Notification letter dated January 21, 2014to affected customers via mail. The letter identified the affected product, description of the problem, actions to be taken by the user, communication, and Dako contact information. The letter was accompanied by a "Recall Form (Product Recall Form to customers)". For questions call 805-566-5464.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NYQ
- Quantity affected
- 49
- Distribution
- Worldwide Distribution - USA Nationwide and in the country of Chile.
- Date initiated
- 2014-01-21
- Date posted
- 2014-02-26
- Date terminated
- 2014-06-04
- Location
- Carpinteria, CA
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