Z-1328-2019 Class II Terminated
FDA device recall Z-1328-2019 was initiated by Opgen Inc on March 18, 2019 and is designated Class II. 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 The recall status is terminated (terminated August 5, 2019). Affected quantity: 80 slides.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- March 18, 2019
- Termination Date
- August 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 slides
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
Distribution Pattern
US Distribution to states of: CT, MI and VA.
Code Information
Lot Number FN80107