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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ADVIA

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  Class 2 Device Recall Siemens ADVIA see related information
Date Initiated by Firm November 06, 2013
Date Posted February 09, 2014
Recall Status1 Terminated 3 on August 10, 2015
Recall Number Z-0940-2014
Recall Event ID 67027
510(K)Number K990346  
Product Classification Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 - Product Code JJE
Product Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400
Product Usage:
The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Code Information ADVIA 1200 V2.00 - 10386841 ADVIA 1200 V2.01 - 10469445 ADVIA 1650 V3.52 - 10318424 ADVIA 1650 V4.01 - 10285281 ADVIA 1800 V2.01 - 10639244 ADVIA 2400 V4.01 - 10639265 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer Reason
for Recall		 The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
FDA Determined
Cause 2		 Software design
Action Siemens sent an Urgent Medical Device Correct letter, dated November 6, 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to retain the recall notification letter with their laboratory records and forward to those who may have received the affected product.
Quantity in Commerce 3759
Distribution Worldwide Distribution and USA Nationwide.
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 = BAYER CORP.
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