Device recall
Z-0042-2014: Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology…
FDA device recall · Class I · Atossa Genetics, Inc.
Key facts
| Recall number (Z-number) | Z-0042-2014 |
|---|---|
| Recall event | 66433 |
| 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 Fluid Laboratory Kit has… |
| Product code | KNW |
| Recalling firm | Atossa Genetics, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 19, 2014 |
| 510(k) numbers | K030443 |
| FEI number | 3009171441 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database