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U.S. Department of Health and Human Services

Class 2 Device Recall Analyzer and Atellica IM 1600 Analyzer

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  Class 2 Device Recall Analyzer and Atellica IM 1600 Analyzer see related information
Date Initiated by Firm February 26, 2018
Create Date May 01, 2018
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-1588-2018
Recall Event ID 79683
510(K)Number K151792  
Product Classification Clinical chemistry Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Code Information UDI 00630414002026
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Gene Victori
914-631-8000
Manufacturer Reason
for Recall		 When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
FDA Determined
Cause 2		 Software design
Action Recall initiated 02/23/2018 Firm released an update software (SW) version (V), 1.12.1, which corrects the behavior. A Mandatory Update (MU) campaign was launched to install the new SW V on all systems, whether or not they are impacted by this behavior. The MU campaign will be tracked to 100% completion globally.
Distribution FL and France Spain Sweden United Kingdom Germany
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 = JJE and Original Applicant = Siemens Healthcare Diagnostics,Inc.
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