Class I Medical Device Recall: Atossa Genetics Mammary Aspiration Specimen Cytology Test (MASCT) System Kit and the ForeCYTE Breast Health Test - Marketing Without Approval or Clearance

Reason for Recall: The MASCT System Kits and ForeCYTE Breast Health Tests are being recalled due to concerns raised by the FDA in a warning letter sent to the company in February 2013. The FDA raised concerns about (1) the current instructions for use...
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Equipment Source Type: news