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Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 1
Recalled June 20, 2018 · FDA recall Z-2182-2018 · Siemens Healthcare Diagnostics
Hazard
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]. · FDA Class II
Units
20373
Sold at
Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.
Description
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].
Product
Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →