| Class 2 Device Recall Dimension Vista VLYTE Fluids Diluent | |
Date Initiated by Firm | October 22, 2009 |
Date Posted | March 10, 2010 |
Recall Status1 |
Terminated 3 on December 16, 2010 |
Recall Number | Z-1039-2010 |
Recall Event ID |
53686 |
510(K)Number | K051087 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product | Dimension Vista V-LYTE Fluids: Diluent catalog number K835 |
Code Information |
Catalog number K835 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, Mailstop 514 PO BOX 6101 Newark DE 19714-6101
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For Additional Information Contact | Technical Solutions Center 800-441-9250 |
Manufacturer Reason for Recall | Results can elevate after sensor replacement. Sodium urine
results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor. |
FDA Determined Cause 2 | Other |
Action | The recalling firm issued an Urgent Field Safety Notice dated October 2009 to all affected customers. Customers were given instruction which minimize urine specimen use and report urine specimen results when QC is acceptable. Sensors are to be replaced when urine QC is out. Replacement sensors are available by contacting the firm at 800-241-0420. Please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance. |
Quantity in Commerce | 150 units |
Distribution | The product was shipped to medical facilities nationwide. The product was also shipped to Australia, Canada, Belgium, France, Germany, Italy, Japan, Malaysia, New Zealand, Netherlands, Portugal, Spain, South Korea, and Switzerland. |
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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