CSL Behring GmbH Emil-Von-Behring-Str. 76 Marburg Germany Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
Brand
CSL Behring GmbH Emil-Von-Behring-Str. 76 Marburg Germany
Lot Codes / Batch Numbers
US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11
Products Sold
US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11
CSL Behring GmbH Emil-Von-Behring-Str. 76 Marburg Germany is recalling Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) due to Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, KS, MO, OH, VA
Page updated: Jan 10, 2026