HER2 Image Analysis Manual Read of HER2 Digital Slides recall
HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope¿¿ System…
Why was HER2 Image Analysis Manual Read of HER2 Digital Slides recalled?
In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification i
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?
23elHCKIT2500, 23elHCKIT5000, 23elHCKIT500.
- Product
- HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope¿¿ System…
- Recalling firm
- Leica Biosystems Imaging, Inc.
- Quantity
- 78
- Distribution
- US Distribution including the states of FL, WA, PA, MS, TX, MN CA, NY, NJ, NC, CO and OH.
- Recall date
- March 19, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)