FDA Recall
Terminated
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.
Recall: Z-2650-2017
·
Initiated October 19, 2011
Recall
- Recall Number
- Z-2650-2017
- Event Number
- 77445
- Firm
- Medtest Holdings, Inc.
- FEI Number
- 1827821
- Product Code
- CGS
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- October 19, 2011
- Posted
- June 29, 2017
- Terminated
- July 24, 2017
- Address
- 5449 Research Dr, Canton, MI, 48188-2261
Description
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.
Reason
Linear performance information in product insert does not match that listed in the approved premarket notification
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.
Distribution
Nationwide Distribution
Quantity
319.922 L