FDA Enforcement
Class II
Terminated
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Recall: Z-2869-2016
·
Reported September 28, 2016
Enforcement
- Recall Number
- Z-2869-2016
- Event ID
- 74989
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Hologic, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 28, 2016
- Initiation Date
- August 22, 2016
- Classification Date
- September 21, 2016
- Termination Date
- February 3, 2017
- Address
- 250 Campus Dr, Marlborough, MA, 01752-3020, United States
Description
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Reason
Incorrect label on the Sertera Biopsy Kit
Code Info
Lot number: 15C10RA.
Distribution
Nationwide.
Quantity
570 units