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U.S. Department of Health and Human Services

Class 3 Device Recall Pointe Scientific Liquid Creatine Kinase Reagent Set

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  Class 3 Device Recall Pointe Scientific Liquid Creatine Kinase Reagent Set see related information
Date Initiated by Firm October 19, 2011
Date Posted June 29, 2017
Recall Status1 Terminated 3 on July 24, 2017
Recall Number Z-2650-2017
Recall Event ID 77445
510(K)Number K972155  
Product Classification Nad reduction/nadh oxidation, cpk or isoenzymes - Product Code CGS
Product Pointe Scientific Liquid Creatine Kinase Reagent Set
Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
Code Information Models: C7522, HC422, HC722, HC922. Lot#'s: 020902; 029902 R1; 029902 R2; 029903; 113204; 129403; 209001. Exp dates 7/2012 to 9/2013.
Recalling Firm/
Manufacturer		 Medtest Holdings, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact Customer Support
800-445-9853
Manufacturer Reason
for Recall		 Linear performance information in product insert does not match that listed in the approved premarket notification
FDA Determined
Cause 2		 Labeling Change Control
Action Pointe Scientific/Technical Bulletin sent notifications on October 19, /2011, TECHNICAL BULLETIN notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities.
Quantity in Commerce 319.922 L
Distribution Nationwide Distribution
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 = CGS and Original Applicant = STANBIO LABORATORY
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