# FDA recall Z-2931-2018 > **CSL Behring GmbH** · Class II · device recall initiated 2018-05-31. ## Product N Latex CDT Kit ## Reason for recall 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. ## Distribution 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 United Kingdom Uruguay ## Key facts - **Recall number:** Z-2931-2018 - **Recalling firm:** CSL Behring GmbH - **Classification:** Class II - **Product type:** device - **Status:** Terminated - **Initiation date:** 2018-05-31 - **Report date:** 2018-09-05 - **Termination date:** 2021-02-12 - **Voluntary/Mandated:** Voluntary: Firm initiated - **Location:** Marburg, N/A, Germany ## Primary source FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2931-2018 ## Citation > AI Analytics. FDA recall Z-2931-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2931-2018. Source: US FDA. Licensed CC0. --- *[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*