STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and inte
FDA device recall Z-0252-2013 · posted 2012-11-06 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite.
- Action taken
- Diagnostica Stago sent an Urgent Field Safety Notice dated June 12, 2012, to all affected customers via email return receipt requested on June 15, 2012. Customers were instructed to follow the instructions in the notification and complete the Customer Verification form and return to the Hotline by fax to 973-644-9348. For additional information, customers were instructed to contact the Hotline at 800-725-0607. For questions regarding this recall call 973-631-1200, ext 2044.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 232 units US; 5 units Canada
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada
- Date initiated
- 2012-06-15
- Date posted
- 2012-11-06
- Date terminated
- 2013-07-19
- 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 SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER (K082248) | Diagnostica Stago, Inc. | 2008-12-12 |