Reported Sep 5, 2018 · Terminated
N Latex CDT Kit
CSL Behring GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CSL Behring GmbH · Emil-von-Behring-Str. 76 · Marburg, N/A · N/A
Is this the product you have?
- N Latex CDT Kit
- Lot codes and dates
- UDI - 842768018534 Lot # 47169
- Exp Date2018-06-15 Lot # 47596
- Exp Date2018-11-30 Lot # 47716
- Exp Date2018-11-30 Lot # 48084
- Exp Date2019-03-21 Lot # 48168
- Exp Date2019-03-21
- Amount recalled
- 6635 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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