CSL Behring GmbH recalls N Latex CDT Kit

Recall date

May 31, 2018

Source

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

Recall number

Z-2931-2018

FDA classification

Class II

Brand / firm

CSL Behring GmbH

Sold / distributed

Domestic - DE, IN, KS, MO & VA Internationally - Australia Austria Belgium Canada China Czech Republic Finland France Germany Hungary India Italy Japan Latvia Lithuania Netherlands Norway Poland Portugal Saudi Arabia Slovakia Slovenia South Africa South Koria Spain Sweden Switzerland Taiwan Turkey…

Why it was recalled

Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC method. CDT results in absolute concentrations may be influenced by patients transferrin levels and, therefore, results are reported as ratio of CDT to total transferrin, called %CDT. As the transferrin determination with N Antiserum to Human Transferrin is not affected, the observed effect leads to calculated %CDT values that show a negative bias of approximately 15% compared to the HPLC method. This could result in a shift of weak positive patient samples into the reference range of 1.19  2.47 %CDT which was derived from a study population of healthy adults. There are no control or calibrator materials that would catch this bias.

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

What was recalled

N Latex CDT Kit