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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific Iron (Ferrozine) R2 Reagent Set

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 Class 2 Device Recall Pointe Scientific Iron (Ferrozine) R2 Reagent Setsee related information
Date Initiated by FirmNovember 16, 2009
Date PostedMarch 02, 2010
Recall Status1 Terminated 3 on June 06, 2011
Recall NumberZ-0903-2010
Recall Event ID 53872
510(K)NumberK864882 
Product Classification Photo Metric Method, Iron (non-heme) - Product Code JIY
ProductPointe Scientific Iron (Ferrozine) R2 Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: HI404-R2. 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
For Additional Information Contact
734-487-8300
Manufacturer Reason
for Recall		Turbidity formation could occur, resulting in invalid test results being reported out.
FDA Determined
Cause 2		Device Design
ActionConsignees 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 Commerce2 sets
DistributionNationwide, 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 CycleTPLC 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) Database510(K)s with Product Code = JIY
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