BEUDAMED
    FDA Recall Terminated

    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997

    Recall: Z-1790-2020 · Initiated March 2, 2020

    Recall

    Recall Number
    Z-1790-2020
    Event Number
    85282
    Firm
    CSL Behring GmbH Emil-Von-Behring-Str. 76 Marburg Germany
    FEI Number
    3003098680
    Product Code
    NAO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 2, 2020
    Terminated
    October 5, 2020

    Description

    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997

    Reason

    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

    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.

    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

    Quantity

    297 PCK US; 1247 PCK OUS