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
|
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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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