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Fluorescence Polarization Immunoassay, Tobramycin

FDA product code LFW · Class 2 · Clinical Toxicology

2
Registered devices
0
Adverse events
2
Recalls
10
510(k) clearances

Devices with this code

CEDIA Tobramycin II Assay — Microgenics CorporationTobramycin — Roche Diagnostics GmbH

Recent recalls

DateFirmReason
2013-10-16Microgenics CorpMicrogenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating
2006-02-10Roche Diagnostics Corp.May have tobramycin over-recovery at the trough level.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.