Atossa ForeCYTE Breast Health Test Recalled for Labeling and Marketing Concerns
Atossa Genetics is recalling ForeCYTE Breast Health Test kits due to FDA concerns regarding instructions for use and promotional claims.
What this means for you
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 driven by labeling and marketing concerns (IFU and promotional claims) rather than a direct physical hazard or reported illness, fitting the criteria for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Atossa Genetics, Inc. is recalling the ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), and associated system and patient sample kits. The recall involves 577 MASCT System kits, 101 Lab Kits, and 2,557 Patient Kits. These products were distributed nationwide in the United States, including specific states and Puerto Rico.
The recall was initiated due to concerns raised by the U.S. Food and Drug Administration (FDA) in a warning letter received by Atossa in February 2013. The FDA identified issues with the current Instructions for Use (IFU) and certain promotional claims used to market the devices. The source text also notes a need for FDA clearance, though the specific details of this requirement are truncated in the provided text.
The affected products are intended for the collection of nipple aspirate fluid for cytological testing to help determine or differentiate normal, premalignant, or malignant cells. Consumers and healthcare providers should stop using these kits and contact Atossa Genetics for further instructions.
The recalled product
- Product
- Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Flui
- Manufacturer
- Atossa Genetics, Inc.
- Category
- Medical Device — Diagnostic Test
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)
- ALL LOTS
Distribution
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