FDA-Device2020-04-29Class II
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
CSL Behring GmbH
Hazard
Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring
Sold states
IN, KS, MO, OH, VA Foreign: Australia, Austria, Bangladesh, Belgium, Canada, China Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hungary India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Republic Korea, Russia Federation, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Taiwan
Affected count
297 PCK US; 1247 PCK OUS
Manufactured in
Emil-Von-Behring-Str. 76, N/A, Marburg, N/A, Germany
Products
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1790-2020Don't want to check this manually?
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