FDA-Device2018-08-08Class II
MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Beckman Coulter Inc.
Hazard
The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.
Sold states
NJ, TX, IA, PA, FL, NE, OH, NY, CA, MO, OK, LA
Affected count
686 boxes
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2599-2018Don't want to check this manually?
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