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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific Creatinine Reagent Set

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  Class 2 Device Recall Pointe Scientific Creatinine Reagent Set see related information
Date Initiated by Firm December 01, 2009
Date Posted March 09, 2010
Recall Status1 Terminated 3 on October 15, 2010
Recall Number Z-1035-2010
Recall Event ID 54094
510(K)Number K830556  
Product Classification Alkaline Picrate, Colorimetry, Creatinine - Product Code CGX
Product Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C7539-150, C7539-625, C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539-R1-120, 8-C7539-R1-500, 8-C7539-R1-1000, 7-C7539-R1-120, 7-C7539-R1-1000, and 7-C7539-R1-500.

For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.
Code Information All lots numbers containing the numbers 923202; exp. 2011-08.
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
734-487-8300
Manufacturer Reason
for Recall		 An additional 10% picric acid was added to the R2 component during production.
FDA Determined
Cause 2		 Process change control
Action Consignees were notified by An Urgent: Medical Device Recall letter, dated 12/1/09, that identified the affected product. Customers were asked to immediately examine their inventory for the affected product and to notify any customers that the product may have been further distributed to by giving them a copy of the recall notice. Customers are to dispose of the affected product immediately. Questions should be directed to the Technical Support Department at (800)757-5313 or (734)487-8300. There is also a Recall Response form attached with this notice.
Quantity in Commerce 892 kits
Distribution Worldwide Distribution -- USA, Bolivia, Greece, Guyana, India, Indonesia, Israel, Kenya, Korea, Malaysia, Mexico, Pakistan, Philippines, Russia, Serbia, Sri Lanka, Tanzania, Trinidad and Ukraine.
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 = CGX and Original Applicant = POINTE SCIENTIFIC, INC.
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