Dako HER2 CISH pharmDx Kit recall
Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor…
Why was Dako HER2 CISH pharmDx Kit recalled?
An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
20031683
- Product
- Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor…
- Recalling firm
- Dako North America Inc.
- Quantity
- 31 kits
- Distribution
- Worldwide Distribution - US Nationwide in the states of: PA, CA, AL, NC and countries of Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Brazil, Canada, Switzerland, Germany, Spain, France, Greece, Italy, Macedonia, Qatar, Romania, Serbia, Sweden, and Turkey.
- Recall date
- July 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)