Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
N Latex CDT Kit Recalled by CSL Behring GmbH Due to Siemens Healthcare Diagnostics has observed a negative bias...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CSL Behring GmbH directly.
Affected Products
N Latex CDT Kit
Quantity: 6635 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 5 states: DE, IN, KS, MO, VA
About CSL Behring GmbH
CSL Behring GmbH has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report