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Radioimmunoassay, Vancomycin
FDA product code LEH · Class 2 · Clinical Toxicology
29
Registered devices
510
Adverse events
12
Recalls
31
510(k) clearances
Devices with this code
Syva® Emit® 2000 Vancomycin Assay — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® VANC — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® Systems, ACS:180® Systems VANC Calibrator — Siemens Healthcare Diagnostics Inc.ONLINE TDM Vancomyin Gen.3 — Roche Diagnostics GmbHQMS Vancomycin Immunoassay — Microgenics CorporationQMS Vancomycin Immunoassay — Microgenics CorporationADVIA Centaur® Vancomycin Calibrator — Siemens Healthcare Diagnostics Inc.Synchron — Beckman Coulter, Inc.ADVIA Centaur® VANC MCM — Siemens Healthcare Diagnostics Inc.Emit® 2000 Vancomycin Assay — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESDimension® Flex® reagent cartridge VANC — Siemens Healthcare Diagnostics Inc.Vancomycin — Roche Diagnostics GmbHONLINE TDM Vancomycin Gen.3 — Roche Diagnostics GmbHVancomycin — Roche Diagnostics GmbHARCHITECT — Abbott GmbHAlinity — ABBOTT LABORATORIESVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Atellica CH Vanc — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® VANC — Siemens Healthcare Diagnostics Inc.ONLINE TDM Vancomycin Gen.3 — Roche Diagnostics GmbHDimension Vista® Flex® reagent cartridge VANC — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHONLINE TDM Vancomyin Gen.3 — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2019-07-23 | Roche Diagnostics Operations, Inc. | Inaccurately Low Sample Results |
| 2019-07-23 | Roche Diagnostics Operations, Inc. | Inaccurately Low Sample Results |
| 2017-02-21 | Ortho-Clinical Diagnostics | Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and |
| 2016-05-26 | Roche Diagnostics Operations, Inc. | Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analyt |
| 2012-07-17 | Siemens Healthcare Diagnostics, Inc. | Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure |
| 2007-12-20 | Seradyn, Inc. | False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results. |
| 2007-04-30 | Roche Diagnostics Corp. | Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: C |
| 2006-03-30 | Beckman Coulter Inc | Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Intern |
| 2005-10-12 | Ortho-Clinical Diagnostics | Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days. |
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