CSL Behring GmbH recalls Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Sie…

Recall date

March 2, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1790-2020

FDA classification

Class II

Brand / firm

CSL Behring GmbH

Sold / distributed

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 S…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997