Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Cant
FDA device recall Z-0900-2010 · posted 2010-03-02 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- Turbidity formation could occur, resulting in invalid test results being reported out.
- Action taken
- Consignees were notified by recall letter dated 11/16/09 and instructed to discard any remaining product. Please call 1-800-757-5313 if you have questions.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JIY
- Quantity affected
- 235 sets
- Distribution
- Nationwide, Australia, Austria, Bolivia, Canada, Cyprus, Egypt, Ghana, Greece, Guyana, India, Indonesia, Israel, Jordan, Kenya, Korea, Lebanon, Macedonia, Malaysia, Mexico, Nicaragua, Nigeria, Pakista
- Date initiated
- 2009-11-16
- Date posted
- 2010-03-02
- Date terminated
- 2011-06-06
- 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 |
|---|---|---|
| FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY (K864882) | Pointe Scientific, Inc., | 1987-01-21 |