FDAMarch 18, 2019device
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 r...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
What to do
FDA enforcement status: Terminated
Brands named
opgen
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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