Siemens Healthcare Diagnostics, Inc. recalls Dimension Gentamicin Flex reagent cartridge, DM GENT, genta
Recalled Product
Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
Hazard / Issue
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.
Issued by
FDA
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