Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one
FDA device recall Z-2773-2015 · posted 2015-09-16 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.
- Action taken
- On 12/12/2014, Field Correction Notice notifications were sent to the affected distributors via electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Pointe Scientifics Technical Service Department at 1-800-757-5313.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CGX
- Quantity affected
- 93 kits
- Distribution
- Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.
- Date initiated
- 2014-12-12
- Date posted
- 2015-09-16
- Date terminated
- 2015-10-29
- 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 |
|---|---|---|
| CREATININE (K830556) | Pointe Scientific, Inc., | 1983-03-24 |