medical Class II Updated 2018-06-20

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

Distribution: Nationwide (United States)
Lot/Code Info: Lots EB8115 BB8159 FB8275
View official government recall

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