Recall Z-0865-2010 ยท JQP Calculator/Data Processing Module, For Clinical Use
Abbott Point of Care Inc.
i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
| Date | Feb 26, 2010 (initiated Sep 29, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 36 |
| Distribution | Nationwide and Foreign: Germany, the United Kingdom, Switzerland and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001387 | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 I-Stat Corp., Oct 5, 2000 |