Hologic Sertera Biopsy Device Recalled for Incorrect Labeling
Hologic is recalling 570 units of the Sertera Biopsy Device due to incorrect labeling on the sterile kit.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as an incorrect label without reporting any injuries, illnesses, or specific functional defects that would elevate the severity to High or Severe.
Plain-English summary
Hologic, Inc. is recalling 570 units of the Sertera Biopsy Device, Sterile, which is used primarily in ultrasound-guided breast biopsies. The recall is being conducted because of an incorrect label on the Sertera Biopsy Kit.
The affected units are identified by Lot number 15C10RA. The products were distributed nationwide. No specific dates of distribution or sales are provided in the source text.
Consumers and healthcare providers should stop using the affected Sertera Biopsy Devices and contact Hologic, Inc. for further instructions or a replacement.
The recalled product
- Product
- Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
- Manufacturer
- Hologic, Inc
- Category
- Medical Device — Biopsy Device
- Hazard
- Affected units
- 570
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: 15C10RA.
Distribution
Distributed nationwide across the United States.
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