Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 ml (Product no. A7561-150) and
FDA device recall Z-0171-2009 · posted 2008-10-22 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.
- Action taken
- Consignees were notified via recall letter dated 8/22/08 and mailed 8/25/08 to examine their inventory, dispose of any recalled product found, and to notify the firm for replacements. Contact Pointe Scientific Inc., at 1-800-757-5313 for assistance.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- CIT
- Quantity affected
- 109 kits
- Distribution
- Nationwide, Bolivia, Ecuador, Greece, Indonesia, Mexico, Nepal, Philippines, Romania and Serbia.
- Date initiated
- 2008-08-25
- Date posted
- 2008-10-22
- Date terminated
- 2009-11-27
- 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 |
|---|---|---|
| LIQUID AST (SGOT)REAGENT SET (K941132) | Pointe Scientific, Inc., | 1994-05-02 |