Z-1790-2020Class II

Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human...

Name: Z-1790-2020 Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human...
Creator: CSL Behring GmbH
Published: 2020-03-02
License: https://open.fda.gov/license/

CSL Behring LLC / initiated 2020-03-02 / Terminated

FDA source

CSL Behring GmbH began a recall of Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997 on 2020-03-02. FDA classified it as Class II and gives the reason as "Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1790-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-02
Posted: 2020-04-23
Terminated: 2020-10-05
Recalling firm: CSL Behring LLC
Product: Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
Product code: NAO Test, Carbohydrate Deficient Transferrin
Reason for recall: Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring
FDA root cause: Under Investigation by firm
Action: Siemens Healthcare Diagnostics issued Urgent Medical Device Correction (UMDC) letter PP-20-002.A.US to the 5 affected customers in the U.S. on March 5, 2020 via FedEx overnight delivery. ( Urgent Field Corrective Action (UFCA) PP20-002.A.OUS was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities). Letter states reason for recall, health risk, and action to take by the Customer Please review this letter with your Medical Director. Discontinue use of and discard the kit lots listed in Table 1. Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in commerce: 297 PCK US; 1247 PCK OUS
Distribution: IN, KS, MO, OH, VA Foreign: Australia, Austria, Bangladesh, Belgium, Canada, China Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hungary India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Republic Korea, Russia Federation, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Taiwan
Product codes and lots: US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1790-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1790-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23

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)