N Latex CDT Kit
Enforcement
- Recall Number
- Z-2931-2018
- Event ID
- 80431
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- CSL Behring GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 5, 2018
- Initiation Date
- May 31, 2018
- Classification Date
- August 25, 2018
- Termination Date
- February 12, 2021
- Address
- Emil-von-Behring-Str. 76, N/A, Marburg, N/A, N/A, Germany
Description
N Latex CDT Kit
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.
UDI - 842768018534 Lot # 47169, Exp Date: 2018-06-15 Lot # 47596, Exp Date: 2018-11-30 Lot # 47716, Exp Date: 2018-11-30 Lot # 48084, Exp Date: 2019-03-21 Lot # 48168, Exp Date: 2019-03-21
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6635 units