Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.
FDA device recall Z-1014-2010 · posted 2010-03-05 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay.
- Action taken
- Consignee was notified by letter dated 7/29/2009 and instructed to identify and notify them at once of this product recall. Product is to be returned or destroyed. Customers with questions should contact the firm directly.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- CIG
- Quantity affected
- 2
- Distribution
- California.
- Date initiated
- 2009-07-29
- Date posted
- 2010-03-05
- Date terminated
- 2010-12-06
- 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 |
|---|---|---|
| TOTAL BILIRUBIN REAGENT SET (K040391) | Pointe Scientific, Inc., | 2004-06-02 |