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U.S. Department of Health and Human Services

Class 2 Device Recall N Latex CDT Kit

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  Class 2 Device Recall N Latex CDT Kit see related information
Date Initiated by Firm March 02, 2020
Create Date April 23, 2020
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-1790-2020
Recall Event ID 85282
510(K)Number K060677  
Product Classification Test, carbohydrate deficient transferrin - Product Code NAO
Product Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum.
Siemens Material Number (SMN): 10445997
Code Information US Lot number: 49822  UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084  Exp. Date: 2020-04-11
Recalling Firm/
Manufacturer		 CSL Behring GmbH
Emil-Von-Behring-Str. 76
Marburg Germany
Manufacturer 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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAO and Original Applicant = DADE BEHRING, INC.
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