Device product
Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441
Z-1706-2020
Product summary
- Event
- Event 85203
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 units
- Official record key
device-enforcement:Z-1706-2020
Official wording
Reason: Extended Expiration Date prior to clearance
Code information: Lot Codes: S119_2174743 S119_2188760 S119_2165333 P119_2149298 S217_04001 1705002 UDI: (01)10190302015103
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Extended Expiration Date prior to clearance