Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615
FDA device recall Z-0912-2010 · posted 2010-03-02 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- A process deviation occurred during the production of the R1 component which may affect its performance.
- Action taken
- Pointe Scientific, Inc. issued an "Urgent: Medical Device Recall" notification dated December 1, 2009. Consignees were instructed to examine their inventory for the affected product and discard the affected product immediately. For further information, contact Pointe Scientific, Inc. Technical Support at 1-800-757-5313 or 1-734-487-8300.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KNK
- Quantity affected
- 12 kits
- Distribution
- Worldwide Distribution -- United States (California, Florida, Kentucky, Michigan, Ohio, Oklahoma and Virginia), Chile and Malaysia.
- Date initiated
- 2009-12-01
- Date posted
- 2010-03-02
- Date terminated
- 2010-10-08
- 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 |
|---|---|---|
| URIC ACID (LIQUID) REAGENT SET (K970560) | Pointe Scientific, Inc., | 1997-03-11 |