i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
This recall has been terminated (originally issued February 26, 2010).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- September 29, 2009
- Posted
- February 26, 2010
- Terminated
- July 1, 2010
- Recall Number
- Z-0865-2010
- Quantity
- 36
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide and Foreign: Germany, the United Kingdom, Switzerland and the Netherlands.
Lot / Code Info
i-STAT Catalog number: 111610 Abbott list number (US and Canada) 08K4501
Root Cause
Software design
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.