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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ADVIA

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 Class 2 Recall
Siemens ADVIA
see related information
Date Posted February 09, 2014
Recall Status1 Open
Recall Number Z-0940-2014
Recall Event ID 67027
Premarket Notification
510(K) Number
K990346 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - 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, Delaware 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
OTHER/UNDETERMINED: Under Investigation by the firm
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 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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