Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C7539-150, C7539-625, C7539-625
FDA device recall Z-1035-2010 · posted 2010-03-09 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- An additional 10% picric acid was added to the R2 component during production.
- Action taken
- Consignees were notified by An Urgent: Medical Device Recall letter, dated 12/1/09, that identified the affected product. Customers were asked to immediately examine their inventory for the affected product and to notify any customers that the product may have been further distributed to by giving them a copy of the recall notice. Customers are to dispose of the affected product immediately. Questions should be directed to the Technical Support Department at (800)757-5313 or (734)487-8300. There is also a Recall Response form attached with this notice.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- CGX
- Quantity affected
- 892 kits
- Distribution
- Worldwide Distribution -- USA, Bolivia, Greece, Guyana, India, Indonesia, Israel, Kenya, Korea, Malaysia, Mexico, Pakistan, Philippines, Russia, Serbia, Sri Lanka, Tanzania, Trinidad and Ukraine.
- Date initiated
- 2009-12-01
- Date posted
- 2010-03-09
- Date terminated
- 2010-10-15
- 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 |
|---|---|---|
| CREATININE (K830556) | Pointe Scientific, Inc., | 1983-03-24 |