Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
This recall has been terminated (originally issued September 21, 2016).
- Company
- Hologic, Inc
- Recall Initiated
- August 22, 2016
- Posted
- September 21, 2016
- Terminated
- February 3, 2017
- Recall Number
- Z-2869-2016
- Quantity
- 570 units
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect label on the Sertera Biopsy Kit
Distribution
Nationwide.
Lot / Code Info
Lot number: 15C10RA.
Root Cause
Labeling Change Control
Action Taken
Hologic notified customers in the United States through Certified letter on 8/22/16. The letter contains instructions of returning the product, provides contact information, and includes a postage-paid return card for the consignee to complete and return to Hologic. Contact technical support at 508-263-2900 or l-800-442:9892 Press Option 6 ).
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