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Class 2 Device Recall Dimension Vista(R) Cuvettes |
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Date Initiated by Firm |
August 08, 2011 |
Date Posted |
October 07, 2011 |
Recall Status1 |
Terminated 3 on December 24, 2013 |
Recall Number |
Z-0031-2012 |
Recall Event ID |
59746 |
510(K)Number |
K051087
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Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical - Product Code JJE
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Product |
Dimension Vista(R) Cuvettes
The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is 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 fluid. Vista (TM) system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.
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Code Information |
Catalog Number KS850 - lots: X05-076-11, X05-081-11, X05-086-11, X05-090-11, X05-091-11, X05-096-11, X05-101-11, X05-108-11, X05-117-11, X05-122-11, X05-125-11, and X05-126-11. |
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 |
Robert J King 302-631-6311
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Manufacturer Reason for Recall |
Siemens Healthcare Diagnostics has confirmed a low frequency defect in the molding of the Cuvettes that may result in Cuvette Ring and Cuvette Loader jams. It
has been determined that the issue is related to a molding defect with the Cuvette flange or "wing" breaking, resulting in an error condition. Therefore, patient results are not impacted.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Siemens Healthcare Diagnostics sent a Urgent Field Safety Notice letter dated August 2011, to all affected customers. The letter identifed the product the problem and the action needed to be taken by customer.
Customers were instructed to discard all cuvette cartridges of the identified lots. Customers were also informed that until a replacement lot is available, if an error is encountered, they may contact the Technical Solutions Center for assistance at (800) 441-9245.
For replacement product , please call the Siemens Atlanta Customer Service Center at (800) 241-0420. |
Quantity in Commerce |
1,786 |
Distribution |
Worldwide Distribution -- USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and Puerto Rico., and the countries of Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Spain, Switzerland, Australia, Japan, South Korea, and Canada. |
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 and Original Applicant = DADE BEHRING, INC.
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