Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinica
FDA device recall Z-1202-2009 · posted 2009-04-17 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- The product performance fails due to precipitation of the R2 component.
- Action taken
- Consignees were notified by "Urgent: Medical Device Recall" letter dated February 2, 2009 and mailed on February 6, 2009, and instructed to conduct the recall to the retail level if they had further distributed the product, to destroy any stocks on hand, and to complete and return the "Recall Return Response Form" via mail, e-mail, or fax (734-483-1592) to Point Scientific, Inc. Direct questions to the firm's Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CIG
- Quantity affected
- 24 kits
- Distribution
- Worldwide Distribution -- USA, Chile and Mexico.
- Date initiated
- 2009-02-02
- Date posted
- 2009-04-17
- Date terminated
- 2010-10-13
- 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 |