Atossa Genetics announced on Friday a recall on its breast fluid device used for cancer detection due to clearance issue found by the U.S Food and Drug Administration.
The Seattle, Washington-based company is known for manufacturing ground-breaking breast health products and services to help women to check and protect their breast from various diseases on their own. One of its main products is the Mammary Aspiration Specimen Cytology Test (MASCT).
MASCT is breast health device designed to collect breast fluid samples which both patients and doctors can use. It doesn't need radiation and needles, and can be conveniently used in the doctor's office. The samples collected in a few minutes by the device can be used to detect and distinguish among normal, abnormal, and cancerous breast cells.
However, the FDA released a warning letter on February 21 saying that the MASCT system missed to comply on additional clearance required. Apparently, the collection process was changed after the agency granted approval to Atossa.
Reuters reported that Atossa chief executive Steven Quay will be submitting a new pre-market application by the end of the month detailing the updated collection process of breast fluid samples.
"We would like to have a presubmission meeting (with the FDA) before filing. Unfortunately, the government shutdown makes the timing of the meeting and the subsequent filing impossible to predict," he said on a conference call with analysts.
For the meantime, the breast health products that were already distributed within the Unites States by its partner drug wholesaler Mckesson Corp would be removed in the market. However, the company didn't give any information when they will resume selling the product.
There were no reported incidences of injuries since the release of the product and even after the changes.
