The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0042-2014·Announced 2013-11-06

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Atossa Genetics is recalling ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT) due to concerns raised by the U.S. Food and Drug Administration (FDA) in a warning letter received by Atossa in February 2013. The…"

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…
Manufacturer
Atossa Genetics, Inc.
Category
Medical Device — Diagnostic Test
Hazard

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

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Related recalls

Same hazard · mis labeling

See all →

Similar recalls