Radioimmunoassay, Vancomycin

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-05-27Open, ClassifiedStorage

  ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.

  transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

• 2016-08-01TerminatedUnder Investigation by firm

  ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.

  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 Analytics P module due method sheets that state an incorrect method comparison against the COBAS INTEGRA 800 analyzer.

• 2012-08-09TerminatedNonconforming Material/Component

  Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.

  Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System.

• 2008-04-29TerminatedDevice Design

  Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.

  False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.

• 2007-06-09TerminatedOther

  Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.

  Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.

• 2006-05-18TerminatedOther

  SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.

  Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Internal QC recovery was as much as 15% lower than the assigned target value.

• 2005-11-18TerminatedOther

  VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626

  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.

• 2004-07-23TerminatedOther

  Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365.

  The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3 (three).

• 2004-07-20TerminatedOther

  Package Insert for TDx/TDxFLx and TDxFLx Phenobarbital II Reagents, REF 9500, item number 69-5162/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

  The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges

• TerminatedUnder Investigation by firm

  Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502

  Inaccurately Low Sample Results