Recall Z-2931-2018— CSL Behring GmbH

Name: FDA recall Z-2931-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-31

Class II · Terminated

Class II FDA medical device recall by CSL Behring GmbH, initiated 2018-05-31, terminated 2021-02-12. It names one FDA 510(k) clearance: K060677. Product: N Latex CDT Kit. Reason: 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..

Recalling firm: CSL Behring GmbH
Classification: Class II
Status: Terminated
Initiated: 2018-05-31
Terminated: 2021-02-12
Firm location: Marburg, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K060677 — N LATEX CDTDade Behring, Inc.·cleared 2006-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.