Recall Z-1328-2019— Opgen Inc
Class II · Terminated
Class II FDA medical device recall by Opgen Inc, initiated 2019-03-18, terminated 2019-08-05. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test.
- Recalling firm
- Opgen Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-18
- Terminated
- 2019-08-05
- Firm location
- Gaithersburg, MD, United States
Product description
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
Reason for recall
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
Data sourced from openFDA. This site is unofficial and independent of the FDA.