Home › Device 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
Tobramycin — Roche Diagnostics GmbHEmit® 2000 Tobramycin Assay — Siemens Healthcare Diagnostics Inc.Syva® Emit® 2000 Tobramycin Assay — Siemens Healthcare Diagnostics Inc.ADVIA® Chemistry TOB_2 Tobramycin_2 Reagents — Siemens Healthcare Diagnostics Inc.ONLINE TDM Tobramycin — Roche Diagnostics GmbHTobramycin ONLINE TDM Tobramycin — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-04-05 | Roche 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 |
| 2007-04-05 | Roche 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 |
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