i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
FDA Recall Z-0865-2010 · Posted 2010-02-26
Recalling FirmAbbott Point of Care Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2009-09-29
Date Terminated2010-07-01
Product Quantity36
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide and Foreign: Germany, the United Kingdom, Switzerland and the Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.