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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems

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 Class 2 Recall
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems
see related information
Date Posted January 21, 2014
Recall Status1 Terminated on August 26, 2014
Recall Number Z-0800-2014
Recall Event ID 67030
Premarket Notification
510(K) Number
K990346 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
Code Information ADVIA 1200 with software versions: V2.00 and V2.01 ADVIA 1650 with software versions V3.52 and V4.01
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark, Delaware 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer Reason
for Recall
An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action The distribution of the Urgent Medical Device Correction letter scheduled to begin on December 17, 2013. ®x Field service personnel will be notified of the Urgent Medical Device Correction Letter via the Siemens Knowledge Base, as well as information regarding placing labels on the customer system to remind the customer that ///// is not a reportable result. ®x The Customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue. ®x Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction.
Quantity in Commerce 1563
Distribution Distributed USA (nationwide) and the country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BAYER CORP.
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