Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge

• • Terminated Z-2182-2018 FDA Class II ·initiated 19 Apr 2018 ·via K062024, on the same 510(k)

  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 calibration curve not showing separation between the Level 1 and Level 2 calibrators. The negative bias observed for patient, QC, and calibrator samples, when using any of the listed lots, has the potential to impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 g/mL [5.4 mol/L].

• • Terminated Z-2181-2018 FDA Class II ·initiated 19 Apr 2018 ·via K062024, on the same 510(k)

  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 calibration curve not showing separation between the Level 1 and Level 2 calibrators.

• • Terminated Z-0408-2013 FDA Class II ·initiated 9 Aug 2012 ·via K062024, on the same 510(k)

  Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation.

• • Terminated Z-1739-2011 FDA Unclassified (pre-2012) ·initiated 30 Nov 2010 ·via K062024, on the same 510(k)

  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 protein methods: ASL, B2MIC, B2MU, CRP,CYSC, HCYS, hcCRP, IGE, IGG3, IGG4, RF, and STFR resulting in inappropriate patient treatment.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K062024 ↗

FDA Product Code

LFM

Device Class

Class II

Regulation

21 CFR Part 862.3300

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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