Z-0865-2010

i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer

Name: Z-0865-2010 i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
Creator: Abbott Point of Care Inc.
Published: 2009-09-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-09-29 / Terminated / root cause: software

FDA source

Abbott Point of Care Inc. began a recall of i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer on 2009-09-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0865-2010
Status: Terminated
Initiated: 2009-09-29
Posted: 2010-02-26
Terminated: 2010-07-01
Recalling firm: Abbott Medical
Product: i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA 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 in commerce: 36
Distribution: Nationwide and Foreign: Germany, the United Kingdom, Switzerland and the Netherlands.
Product codes and lots: i-STAT Catalog number: 111610 Abbott list number (US and Canada) 08K4501

Product code JQP

K001387Class III-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. / cleared 2000-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)