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U.S. Department of Health and Human Services

Class 2 Device Recall PROT 1 CAL

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  Class 2 Device Recall PROT 1 CAL see related information
Date Initiated by Firm May 23, 2017
Create Date November 28, 2017
Recall Status1 Terminated 3 on March 30, 2018
Recall Number Z-0173-2018
Recall Event ID 77381
510(K)Number K082503  
Product Classification Immunochemical, ceruloplasmin - Product Code CHN
Product Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
Code Information Lot numbers: 6JC001, 6JC001C, 6JC001G (exp. date 2018-01-11); 6MC001, 6MC001C (exp. date 2018-04-29); 6CC001A, 6CC001B, 6CC001F (exp. date 2017-07-14); 6FC001A, 6FC001C, 6FC001E (exp. 2017-10-27); --- Lot # (UDI): 6CC001A (008427680244436CC001A20170714),  6CC001B (008427680244436CC001B20170714),  6CC001F (008427680244436CC001F20170714),  6FC001A (008427680244436FC001A20171027),  6FC001C (008427680244436FC001C20171027),  6FC001E (008427680244436FC001E20171027),  6JC001 (008427680244436JC00120180111),  6JC001C (008427680244436JC001C20180111),  6JC001G (008427680244436JC001G20180111),  6MC001 (008427680244436MC00120180429),  6MC001C (008427680244436MC001C20180429).
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		 Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens issued an Urgent Medical Device Correction (UMDC) letter (PP-17-012.A.US, dated May 23, 2017) to US customers on May 23, 2017 and an Urgent Field Safety Notice (UFSN) to customers Outside the US in May 2017. Customers were instructed in the letter to use re-assigned CER values for the lots indicated of PROT1 CAL and PROT1 CON L, M, and H. In the US, the method of distribution is FEDEX and outside the US, the distribution is determined at the country level. Customers were requested to complete Effectiveness Check questionnaire attached to the UMDC/UFSN and return to Siemens within 30 days.
Distribution Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South
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 = CHN and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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