Home / Recalls / Medical Devices
Clinical Diagnostic Solutions, Inc. recalls Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Recalled February 12, 2020 · FDA recall Z-1001-2020 · Clinical Diagnostic Solutions
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. · FDA Class II
Units
261
Sold at
Worldwide distribution. US Nationwide, Venezuela, Africa, Italy, Brazil, and Ukraine. No governmental, Canadian, or Mexican consignees.
Description
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.
Product
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Manufacturer(s)
Clinical Diagnostic Solutions, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →