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Class 2 Device Recall Dimension Vista Systems LOCI Thyroid Stimulating Hormone (TSH) Reagent |
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Date Initiated by Firm |
April 20, 2015 |
Date Posted |
June 04, 2015 |
Recall Status1 |
Terminated 3 on December 13, 2016 |
Recall Number |
Z-1708-2015 |
Recall Event ID |
71096 |
510(K)Number |
K140859
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Product Classification |
Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
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Product |
Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.
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Code Information |
Catalog Number K6412, Material Number 10445104, Lot Number 14237AA, exp. 2015-08-25. |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr Ms 514 PO BOX 6101 Newark DE 19702-2466
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For Additional Information Contact |
Customer Support 800-441-9250
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Manufacturer Reason for Recall |
Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a Flex well.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Siemens sent an Urgent Medical Device Recall notice, dated April 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
- Review this letter with your Medical Doctor.
- Discontinue use and discard your remaining inventory of the reagent lot listed in
Table 1.
- Indicate your replacement product needs on the attached Field Correction Effectiveness Check form and fax to (312) 275-7795 within 30 days. Siemens will replace any unused inventory of the affected lot at no charge.
We apologize for the inconvenience this situation may cause.. If you have any questions, please contact your Siemens Customer Care Center Technical Solutions at 800-441-9258, or your local Siemens technical support representative. |
Quantity in Commerce |
2256 |
Distribution |
Worldwide Distribution - Nationwide and to the countries of : Australia, Japan, New Zealand, Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Netherlands, Portugal, and Slovakia. |
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 = JLW and Original Applicant = Siemens Healthcare Diagnostics Inc.
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