Device product
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Z-2869-2016
Product summary
- Firm
- Hologic, Inc
- Event
- Event 74989
- Status
- Terminated
- Classification
- Class II
- Quantity
- 570 units
- Official record key
device-enforcement:Z-2869-2016
Official wording
Reason: Incorrect label on the Sertera Biopsy Kit
Code information: Lot number: 15C10RA.
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
Incorrect label