Recall Z-2869-2016 ยท KNW Instrument, Biopsy
Hologic, Inc
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
| Date | Sep 21, 2016 (initiated Aug 22, 2016) |
| Status | Terminated |
| Reason | Incorrect label on the Sertera Biopsy Kit |
| Root cause | Labeling Change Control |
| Action | 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 ). |
| Quantity | 570 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150169 | Sertera Biopsy Device Hologic, Inc., Aug 14, 2015 |