STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasm
FDA device recall Z-1044-2012 · posted 2012-02-16 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P.
- Action taken
- Stago sent a recall letters via email dated August 23, 2011 to all affected customers . The letter identified the product, description of problem, and corrective actions to be taken. Customers were asked to immediately examine their inventory and follow the corrective actions provided. Customers were instructed to complete the response form attached to the letter. Because of incorrect manufacturer's instructions included in the initial letter another letter was emailed by the firm on August 30, 2011. For questions or technical assistance for updating the parameters please call the Diagnostica Stago 24 hour hotline at 1-800-725-0607.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GGN
- Quantity affected
- 1259 units
- Distribution
- Worldwide Distribution and USA (Nationwide) and including Canada
- Date initiated
- 2011-08-23
- Date posted
- 2012-02-16
- Date terminated
- 2013-09-04
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STA SYSTEM CONTROL [N] + [P] KIT (K943518) | American Bioproducts Co. | 1995-03-21 |