i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
FDA device recall Z-0865-2010 · posted 2010-02-26 · Terminated
Recall details
- Recalling firm
- Abbott Point of Care Inc.
- Reason for recall
- Abbott Point of Care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the incorrect patient name, order number of comment being included in the CDS test record only.
- Action taken
- Urgent Recall Notification letters were sent by Fed Ex to all US customers on September 29, 2009 and worldwide on October 1, 2009. Questions should be directed to Abbott Point of Care Technical Support at 1-800-366-8010, Option 1.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 36
- Distribution
- Nationwide and Foreign: Germany, the United Kingdom, Switzerland and the Netherlands.
- Date initiated
- 2009-09-29
- Date posted
- 2010-02-26
- Date terminated
- 2010-07-01
- Location
- Princeton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 (K001387) | I-Stat Corp. | 2000-10-05 |