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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific Iron (Ferrozine) R1 Reagent Set

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  Class 2 Device Recall Pointe Scientific Iron (Ferrozine) R1 Reagent Set see related information
Date Initiated by Firm November 16, 2009
Date Posted March 02, 2010
Recall Status1 Terminated 3 on June 06, 2011
Recall Number Z-0902-2010
Recall Event ID 53872
510(K)Number K864882  
Product Classification Photo Metric Method, Iron (non-heme) - Product Code JIY
Product Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: HI404-R1.

Clinical chemistry reagent for the quantitative determination of iron in serum.

Code Information All lot numbers containing the numbers 735401 or 816501.
Recalling Firm/
Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
Manufacturer Reason
for Recall
Turbidity formation could occur, resulting in invalid test results being reported out.
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 3 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

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) Database 510(K)s with Product Code = JIY and Original Applicant = POINTE SCIENTIFIC, INC.