Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H754
FDA device recall Z-1200-2009 · posted 2009-04-27 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- The R1 reagent has microbial contamination.
- Action taken
- Consignees were notified by "Urgent: Medical Device Recall" letter dated January 29, 2009, to conduct the recall to the retail level, to examine inventory and dispose of affected stocks on hand, and to complete the "Recall Return Response Form". Consignees were instructed to return their completed forms via mail, fax (1-734-483-1592) or e-mail to Pointe Scientific, Inc. (PS). Direct questions about the recall to PS Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LBR
- Quantity affected
- 497 kits, 93L
- Distribution
- Worldwide Distribution -- US, Chile, Dominican Republic, Egypt, Ghana, Greece, India, Israel, Italy, Jamaica-West Indies, Korea, Malaysia, Mexico, Philippines, Poland, Romania, Serbia, Trinidad-West I
- Date initiated
- 2009-01-29
- Date posted
- 2009-04-27
- Date terminated
- 2010-10-20
- 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 |
|---|---|---|
| AUTOHDL CHOLESTEROL REAGENT SET (K992002) | Pointe Scientific, Inc., | 1999-08-05 |