Class 2 Device Recall Pointe Scientific Creatinine Reagent Set

• Date Initiated by Firm: December 01, 2009
• Date Posted: March 09, 2010
• Recall Status: Terminated 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: 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