FDAnews Device Daily Bulletin

Atossa Genetics’ Breast Health Tests Subject of Class I Recall

Nov. 15, 2013

Seattle-based Atossa Genetics has initiated a Class I recall of all lots of its Mammary Aspiration Specimen Cytology Test (MASCT) and the accompanying patient sample kit, along with the ForeCYTE Breast Health Test Kit, manufactured between Jan. 9 and Sept. 13, 2013.

The recall, initiated Sept. 19 and posted to the FDA’s website Nov. 12, follows a February warning letter citing the company for unapproved marketing claims relating to the approval status of both tests. The agency found certain claims on Atossa’s website to be misleading:

  • The website claimed that the ForeCYTE breast health test kit is FDA-approved, when in fact the test is not approved for any indication; and

  • The website claimed that the FDA had decided the MASCT system could be used to differentiate between normal breast cells and premalignant or malignant breast cells, whereas the device is only approved to collect mammary fluid samples.

Women who see these statements might forgo critical tests such as mammograms or biopsies, the warning letter says, adding there is also a possibility of false negative and false positive results with both tests.

The warning letter also raised concerns about Atossa’s instructions for use on the devices and the need for FDA clearance for modifications made to the Nipple Aspirate fluid specimen collection system.

In a statement on the recall, Atossa said it was unaware of any adverse events or injuries related to the recalled products. The company is working with the FDA to complete the voluntary recall.

Atossa did not return a request for comment by press time. View the recall notice at http://www.fdanews.com/ext/files/11-15-13-Atossa.pdf. — Lena Freund

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