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Terminated

Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.

FDA Recall Z-2869-2016 · Posted 2016-09-21

Recalling FirmHologic, Inc
Recall StatusTerminated
Product CodeKNW
Date Initiated2016-08-22
Date Terminated2017-02-03
Product Quantity570 units

Reason for Recall

Incorrect label on the Sertera Biopsy Kit

Firm 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 ).

Root Cause

Labeling Change Control

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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