Abbott Laboratories MKWClass II

Cyclosporine

Abbott Laboratories's record for this product code

MDR events186All time

Recalls1All time

510(k) clearances1All time

Recent MDR events

186 adverse event reports on file

Recalls

1 recall events for this product code

TerminatedNov 4, 2011
The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision.
View FDA record ↗

510(k) clearances

1 clearances for this product code

K040761Apr 30, 2004
AXSYM CYCLOSPORINE