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U.S. Department of Health and Human Services

Class 3 Device Recall ADVIA Chemistry Enzyme 2 Calibrator

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  Class 3 Device Recall ADVIA Chemistry Enzyme 2 Calibrator see related information
Date Initiated by Firm February 23, 2017
Date Posted March 15, 2017
Recall Status1 Terminated 3 on May 09, 2018
Recall Number Z-1712-2017
Recall Event ID 76695
510(K)Number K103836  
Product Classification Calibrator, primary - Product Code JIS
Product ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture

Product Usage:
Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
Code Information Lots 6JD079 and 6MD042
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		 Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens mailed an Urgent Medical Device Correction Notice to affected customers on 02/21/2017. The notice informed calibrator customers of the reason for the correction, risk to health, and actions to be taken by customers who are in the process of converting from the fixed factor to the enzyme calibrated assay and information for customers who had already converted, until the investigation is complete.
Quantity in Commerce 314 calibrators
Distribution Worldwide Distribution - United States Nationwide: Denmark Sweden Norway Great Britain Belgium Netherlands Spain Israel Switzerland France Portugal Greece Germany Slovenia Czech Republic Hong Kong Colombia Korea Australia
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 = JIS and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS INC
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