Reported Sep 28, 2016 · Terminated
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 250 Campus Dr · Marlborough, MA · 01752-3020
Is this the product you have?
- Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
- Lot codes and dates
- Lot number15C10RA
- Amount recalled
- 570 units
Where it was sold
- Nationwide
Why it was recalled
Incorrect label on the Sertera Biopsy Kit
This product could cause temporary or reversible health problems — stop using it.
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