Immundiagnostik Lactoferrin ELISA Kit Recalled for Lacking FDA 510(k) Clearance
IMMUNDIAGNOSTIK Inc. has recalled the IDK Lactoferrin ELISA diagnostic kit because it was marketed without the required FDA 510(k) premarket notification. No illnesses or injuries have been reported.
- Product
- Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
- Category
- Medical Device
- Distribution
- Distributed nationwide