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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific Uric Acid (Liquid) Reagent Set

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 Class 2 Device Recall Pointe Scientific Uric Acid (Liquid) Reagent Setsee related information
Date Initiated by FirmDecember 01, 2009
Date PostedMarch 02, 2010
Recall Status1 Terminated 3 on October 08, 2010
Recall NumberZ-0912-2010
Recall Event ID 54112
510(K)NumberK970560 
Product Classification Acid, uric, uricase (colorimetric) - Product Code KNK
ProductPointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
Code Information All lot numbers containing the numbers 918301; exp. 2011-01.
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
734-487-8300
Manufacturer Reason
for Recall		A process deviation occurred during the production of the R1 component which may affect its performance.
FDA Determined
Cause 2		Device Design
ActionPointe Scientific, Inc. issued an "Urgent: Medical Device Recall" notification dated December 1, 2009. Consignees were instructed to examine their inventory for the affected product and discard the affected product immediately. For further information, contact Pointe Scientific, Inc. Technical Support at 1-800-757-5313 or 1-734-487-8300.
Quantity in Commerce12 kits
DistributionWorldwide Distribution -- United States (California, Florida, Kentucky, Michigan, Ohio, Oklahoma and Virginia), Chile and Malaysia.
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 = KNK
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