FDA-Device2020-02-12Class II
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Clinical Diagnostic Solutions, Inc.
Hazard
A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.
Sold states
Worldwide distribution. US Nationwide, Venezuela, Africa, Italy, Brazil, and Ukraine. No governmental, Canadian, or Mexican consignees.
Affected count
261
Manufactured in
1800 NW 65th Ave, N/A, Plantation, FL, United States
Products
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1001-2020Don't want to check this manually?
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