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Opgen Inc recalls CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro
Recalled May 22, 2019 · FDA recall Z-1328-2019 · Opgen
Hazard
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test · FDA Class II
Units
80 slides
Sold at
US Distribution to states of: CT, MI and VA.
Description
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
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
Manufacturer(s)
Opgen Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →