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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista Intelligent Lab Systems

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 Class 2 Device Recall Dimension Vista Intelligent Lab Systemssee related information
Date Initiated by FirmNovember 05, 2014
Date PostedDecember 20, 2014
Recall Status1 Terminated 3 on October 06, 2017
Recall NumberZ-0838-2015
Recall Event ID 69687
510(K)NumberK051087 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductDimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
Code Information Material Nos.: 10284473, 10488224,  10444801, and 10444802
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information ContactCustomer Support
800-441-9250
Manufacturer Reason
for Recall		Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.
FDA Determined
Cause 2		Device Design
ActionAn Urgent Medical Device Correction, dated November 2014, was issued on November 4th, 2014 to inform customers that Siemens Healthcare Diagnostics has confirmed that reagent probe performance on Dimension Vista systems may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server. Instructions for replacing an associated reagent probe were provided to resolve the issue. Customers are to retain the letter for their laboratory records and forward it to anyone who has received the affected product. Customers are also to complete and return the Field Correction Effectiveness Check Form. Customer should direct their questions to their Siemens Customer Care Center - Technical Solutions at 1-800-441-9250 or their local Siemens technical support representative.
Quantity in Commerce1,949
DistributionWorldwide Distribution -- Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, and United States.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JJE
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