Date Initiated by Firm | December 17, 2013 |
Date Posted | January 21, 2014 |
Recall Status1 |
Terminated 3 on August 26, 2014 |
Recall Number | Z-0800-2014 |
Recall Event ID |
67030 |
510(K)Number | K990346 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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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 DE 19702-2466
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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 | Software 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 | Worldwide Distribution. USA nationwide and the country of Canada. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JJE
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