Device product
CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides rapid identification of E. coli, K. pneumoniae and P. aeruginosa directly from Gram-negative blood cultures
Z-1328-2019
Product summary
- Firm
- Opgen Inc
- Event
- Event 82665
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 slides
- Official record key
device-enforcement:Z-1328-2019
Official wording
Reason: May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
Code information: Lot Number FN80107
Distribution pattern: US Distribution to states of: CT, MI and VA.
Derived failure modes
-
Unknown
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test