Sertera Biopsy Device recalled over labeling errors

Recall date

August 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-2869-2016

FDA classification

Class II

Brand / firm

Hologic, Inc

Sold / distributed

Nationwide.

Why it was recalled

Incorrect label on the Sertera Biopsy Kit

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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