Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK e
FDA device recall Z-2650-2017 · posted 2017-06-29 · Terminated
Recall details
- Recalling firm
- Medtest Holdings, Inc.
- Reason for recall
- Linear performance information in product insert does not match that listed in the approved premarket notification
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- CGS
- Quantity affected
- 319.922 L
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-10-19
- Date posted
- 2017-06-29
- Date terminated
- 2017-07-24
- Location
- Canton, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CREATINE KINASE (CK) (K972155) | Stanbio Laboratory | 1997-07-17 |