Z-2931-2018Class II

N Latex CDT Kit

Name: Z-2931-2018 N Latex CDT Kit
Creator: CSL Behring GmbH
Published: 2018-05-31
License: https://open.fda.gov/license/

CSL Behring LLC / initiated 2018-05-31 / Terminated / root cause: manufacturing process

FDA source

CSL Behring GmbH began a recall of N Latex CDT Kit on 2018-05-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2931-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-31
Posted: 2018-08-25
Terminated: 2021-02-12
Recalling firm: CSL Behring LLC
Product: N Latex CDT Kit
Product code: NAO Test, Carbohydrate Deficient Transferrin
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On May 31, 2018 Siemens Healthcare Diagnostics issued Urgent Medical Device Correction notices (UMDC) PP18-002.A.US to the 4 affected customers in the U.S. Actions to be Taken by the Customer are as follows: Siemens Healthcare Diagnostics has assigned optimized values to the affected lots of standards and controls included in the kit lots. Those lots of standards and controls can be used with the revised assigned values and acceptance ranges. As per Urgent Medical Device Correction (UMDC) PP18-001.A.US, customers were instructed to: - Recalibrate your CDT method with N CDT Standard lots listed in the UMDC letter, using the revised assigned values provided in the UMDC letter. - Use the revised assigned values and respective ranges of the N CDT Controls provided in the UMDC letter. - For BN ProSpec and Atellica NEPH 630 customers, a new Lot Data CD as well as new Secure Download Files are expected to be available in June 2018, including the revised CDT target values for N CDT Standard, N CDT Control 1 and N CDT Control 2. - Please make sure that the values you manually entered according to this information are not overwritten by using an older Lota Data CD/Secure Download File afterwards. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter and the Urgent Field Corrective Action letter within 30 days.
Quantity in commerce: 6635 units
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2931-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2931-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25

Product code NAO

K060677Class IN Latex CdtDade Behring, Inc. / cleared 2006-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)