CSL Behring GmbH: Medical Device Recall in 2018 - (Recall #: Z-2931-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

N Latex CDT Kit

Product Classification:

Class II

Date Initiated: May 31, 2018

Date Posted: September 5, 2018

Recall Number: Z-2931-2018

Event ID: 80431

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.

Status: Terminated

Product Quantity: 6635 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated