FDA-Device2016-09-28Class II
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Hologic, Inc
Hazard
Incorrect label on the Sertera Biopsy Kit
Sold states
Nationwide.
Affected count
570 units
Manufactured in
250 Campus Dr, Marlborough, MA, United States
Products
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2869-2016Don't want to check this manually?
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