FDA-Device2018-06-20Class II
Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
Siemens Healthcare Diagnostics, Inc.
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.
Sold states
Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.
Affected count
7543
Manufactured in
500 Gbc Dr Ms 514, Po Box 6101, Newark, DE, United States
Products
Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2181-2018Don't want to check this manually?
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