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Class 2 Device Recall Pointe Scientific Total Iron Reagent Set |
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Date Initiated by Firm |
November 16, 2009 |
Date Posted |
March 02, 2010 |
Recall Status1 |
Terminated 3 on June 06, 2011 |
Recall Number |
Z-0900-2010 |
Recall Event ID |
53872 |
510(K)Number |
K864882
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Product Classification |
Photo Metric Method, Iron (non-heme) - Product Code JIY
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Product |
Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7505-120, I7505-500.
Clinical chemistry reagent for the quantitative determination of iron in serum. |
Code Information |
All lot numbers containing the numbers 735401 or 816501. |
Recalling Firm/ Manufacturer |
Pointe Scientific, Inc. 5449 Research Dr Canton MI 48188
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For Additional Information Contact |
734-487-8300
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Manufacturer Reason for Recall |
Turbidity formation could occur, resulting in invalid test results being reported out.
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FDA Determined Cause 2 |
Device Design |
Action |
Consignees were notified by recall letter dated 11/16/09 and instructed to discard any remaining product.
Please call 1-800-757-5313 if you have questions. |
Quantity in Commerce |
235 sets |
Distribution |
Nationwide, Australia, Austria, Bolivia, Canada, Cyprus, Egypt, Ghana, Greece, Guyana, India, Indonesia, Israel, Jordan, Kenya, Korea, Lebanon, Macedonia, Malaysia, Mexico, Nicaragua, Nigeria, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Trinidad, Turkey, Ukraine and Venezuela. |
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 = JIY and Original Applicant = POINTE SCIENTIFIC, INC.
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