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U.S. Department of Health and Human Services

Class 2 Device Recall Hologic Inc. Sertera Biopsy Device

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  Class 2 Device Recall Hologic Inc. Sertera Biopsy Device see related information
Date Initiated by Firm August 22, 2016
Date Posted September 21, 2016
Recall Status1 Terminated 3 on February 03, 2017
Recall Number Z-2869-2016
Recall Event ID 74989
510(K)Number K150169  
Product Classification Instrument, biopsy - Product Code KNW
Product Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Code Information Lot number: 15C10RA.
Recalling Firm/
Manufacturer		 Hologic, Inc
250 Campus Dr
Marlborough MA 01752-3020
For Additional Information Contact SAME
508-263-8920
Manufacturer Reason
for Recall		 Incorrect label on the Sertera Biopsy Kit
FDA Determined
Cause 2		 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 in Commerce 570 units
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNW and Original Applicant = Hologic, INC
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