N Latex CDT Kit
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics recalled certain lots of the N Latex CDT Kit because measurements showed a negative bias of approximately 15% compared to the standard HPLC method. The carbohydrate-deficient transferrin (CDT) test results are reported as a percentage ratio, and this bias could cause some weakly positive patient samples to incorrectly fall within the normal reference range of 1.19–2.47 %CDT. The issue occurs because the affected kit lots underestimate CDT values, and no control or calibrator materials in the kit would detect this problem.
The recall affected 6,635 units distributed domestically in Delaware, Indiana, Kansas, Missouri, and Virginia, as well as internationally across multiple countries including Australia, Canada, France, Germany, Japan, South Korea, Spain, the United Kingdom, and others. The affected lots include Lot #47169 (expiring June 15, 2018), Lot #47596 (expiring November 30, 2018), Lot #47716 (expiring November 30, 2018), Lot #48084 (expiring March 21, 2019), and Lot #48168 (expiring March 21, 2019). The source does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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 Quantity: 6635 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.