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
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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
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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.
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510(K) Database | 510(K)s with Product Code = CGS
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