Date Initiated by Firm | February 26, 2018 |
Create Date | May 01, 2018 |
Recall Status1 |
Terminated 3 on May 12, 2020 |
Recall Number | Z-1586-2018 |
Recall Event ID |
79683 |
510(K)Number | K151792 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product | Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens. |
Code Information |
UDI 00630414007960 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
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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 |
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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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