Sertera Biopsy Device recall
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Why was Sertera Biopsy Device recalled?
Incorrect label on the Sertera Biopsy Kit
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?
Lot number: 15C10RA.
- Product
- Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
- Recalling firm
- Hologic, Inc
- Quantity
- 570 units
- Distribution
- Nationwide.
- Recall date
- September 28, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)