FDA Device Intelligence
HomeDevice types › KLB

Radioimmunoassay, Tobramycin

FDA product code KLB · Class 2 · Clinical Toxicology

6
Registered devices
2
Adverse events
2
Recalls
23
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2007-04-05Roche Diagnostics Corp.Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM
2007-04-05Roche Diagnostics Corp.Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.