CS011 GNR PNA FISH Control Slide recalled over E. coli risk

Recall date

March 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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…

Recall number

Z-1328-2019

FDA classification

Class II

Brand / firm

Opgen Inc

Sold / distributed

US Distribution to states of: CT, MI and VA.

Why it was recalled

May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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