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U.S. Department of Health and Human Services

Class 3 Device Recall Pointe Scientific Creatinine Reagent

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  Class 3 Device Recall Pointe Scientific Creatinine Reagent see related information
Date Initiated by Firm December 12, 2014
Date Posted September 16, 2015
Recall Status1 Terminated 3 on October 29, 2015
Recall Number Z-2773-2015
Recall Event ID 71974
510(K)Number K830556  
Product Classification Alkaline picrate, colorimetry, creatinine - Product Code CGX
Product Pointe Scientific Creatinine Reagent
Catalog number C7539-150
in vitro diagnostic
C7539-150 kit includes one R1 and one R2 bottle.
R1: HDPE plastic bottle. 120 ml fill.
R2: HDPE plastic bottle. 90 ml fill.
Code Information C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03 
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact Customer Support
734-483-1592
Manufacturer Reason
for Recall		 Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.
FDA Determined
Cause 2		 Process control
Action On 12/12/2014, Field Correction Notice notifications were sent to the affected distributors via electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Pointe Scientifics Technical Service Department at 1-800-757-5313.
Quantity in Commerce 93 kits
Distribution Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.
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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