Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
FDA device recall Z-2869-2016 · posted 2016-09-21 · Terminated
Recall details
- Recalling firm
- Hologic, Inc
- Reason for recall
- Incorrect label on the Sertera Biopsy Kit
- 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 ).
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 570 units
- Distribution
- Nationwide.
- Date initiated
- 2016-08-22
- Date posted
- 2016-09-21
- Date terminated
- 2017-02-03
- Location
- Marlborough, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Sertera Biopsy Device (K150169) | Hologic, Inc. | 2015-08-14 |