Device product
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Z-2113-2014
Product summary
- Event
- Event 68709
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 kits
- Official record key
device-enforcement:Z-2113-2014
Official wording
Reason: Product was distributed without 510(k) approval.
Code information: Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.
Distribution pattern: Brazil and Ecuador. No US distribution
Derived failure modes
-
Unknown
Product was distributed without 510(k) approval.