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Enzyme Immunoassay, Gentamicin

FDA product code LCD · Class 2 · Clinical Toxicology

24
Registered devices
67
Adverse events
13
Recalls
37
510(k) clearances

Devices with this code

VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Syva® Emit® 2000 Gentamicin Plus Assay — Siemens Healthcare Diagnostics Inc.Synchron — Beckman Coulter, Inc.GENT — RANDOX LABORATORIES LIMITEDGENTC — Microgenics CorporationQMS Gentamycin Immunoassay — Microgenics CorporationARCHITECT — Abbott GmbHDimension Vista® Flex® reagent cartridge GENT — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHAtellica CH Gent — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® GENT — Siemens Healthcare Diagnostics Inc.Alinity — ABBOTT LABORATORIESSyva® Emit® 2000 Gentamicin Plus Calibrators — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® Systems, ACS:180® Systems GENT Calibrator — Siemens Healthcare Diagnostics Inc.Dimension® Flex® reagent cartridge GENT — Siemens Healthcare Diagnostics Inc.QMS Gentamicin Assay — Microgenics CorporationADVIA® Chemistry GENT_2 Gentamicin_2 Reagents — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® Systems Gentamicin Calibrator — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® Gentamicin MCM — Siemens Healthcare Diagnostics Inc.CEDIA Gentamicin II Assay — Microgenics CorporationEmit® 2000 Gentamicin Plus Assay — Siemens Healthcare Diagnostics Inc.CEDIA Gentamicin II — Roche Diagnostics GmbHCEDIA Gentamicin II (GENTC) — Microgenics CorporationARCHITECT — ABBOTT LABORATORIES

Recent recalls

DateFirmReason
2020-04-24Abbott Gmbh & Co. KGAbbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show in
2018-08-13bioMerieux, Inc.Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Ge
2018-08-13bioMerieux, Inc.Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Ge
2018-04-19Siemens Healthcare Diagnostics, Inc.The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the cali
2018-04-19Siemens Healthcare Diagnostics, Inc.The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the cali
2010-11-30Siemens Healthcare Diagnostics, Inc.False elevation of Dimension Vista(R) Gentamicin results for patients and QC when prior reagent aspirated by the reagent probe is any of the following plasma pr
2009-10-07Roche Diagnostics Operations, Inc.A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.
2009-10-07Roche Diagnostics Operations, Inc.A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.
2009-10-07Roche Diagnostics Operations, Inc.A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.
2009-02-19Beckman Coulter Inc.The reagent produces false low test results. Beckman Coulter has confirmed low recovery of values at the low end of the therapeutic range (<1.5 ug/mL, <3.13 um

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