Abbott Point of Care Inc. i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
Brand
Abbott Point of Care Inc.
Lot Codes / Batch Numbers
i-STAT Catalog number: 111610 Abbott list number (US and Canada) 08K4501
Products Sold
i-STAT Catalog number: 111610 Abbott list number (US and Canada) 08K4501
Abbott Point of Care Inc. is recalling i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer due to Abbott Point of Care has determined that it is possible under certain circumstances that some test records could have their status update messages mis. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026