FDA recall Z-1328-2019

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 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

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

Key facts

Status

Terminated

Initiation date

2019-03-18

Report date

2019-05-22

Termination date

2019-08-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gaithersburg, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1328-2019