Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; C
FDA device recall Z-1091-2009 · posted 2009-03-12 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- The product is unable to maintain the specification for linearity through the shelf life of the product.
- Action taken
- Consignees were notified via an Urgent: Medical Device Recall letter dated 11/3/08 that all test results obtained with these lots are questionable and that attending physicians should be informed to determine whether additional testing is required. Also, consignees should examine their inventories for any of the lot numbers listed and dispose of them. If the product has been further distributed, identify customers and notify them of the product recall by including a copy of the recall letter. The Recall Return Response Form should be completed and returned and upon receipt Pointe Scientific will replace any disposed of reagent. Questions should be directed to the Technical Support Department at 1-800-757-5313.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 1500 liters
- Distribution
- Worldwide Distribution -- USA, Hong Kong, Indonesia, Israel, Jordan, Mexico, Nigeria, Poland, Russia, Serbia, Sri Lanka, Trinidad, and Venezuela.
- Date initiated
- 2008-11-03
- Date posted
- 2009-03-12
- Date terminated
- 2009-12-03
- 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 |
|---|---|---|
| GLUCOSE OXIDASE (K810674) | Pointe Scientific, Inc., | 1981-03-31 |