Recall Z-2650-2017 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Medtest Holdings, Inc.
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.
| Date | Jun 29, 2017 (initiated Oct 19, 2011) |
| Status | Terminated |
| Reason | Linear performance information in product insert does not match that listed in the approved premarket notification |
| Root cause | 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 | 319.922 L |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972155 | CREATINE KINASE (CK) Stanbio Laboratory, Jul 17, 1997 |