Z-0926-2018Class II

i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200...

Name: Z-0926-2018 i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200...
Creator: Abbott Point Of Care Inc.
Published: 2017-09-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-09-12 / Terminated / root cause: design

FDA source

Abbott Point Of Care Inc. began a recall of i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255) on 2017-09-12. FDA classified it as Class II and gives the reason as "Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action Ranges, and Custom Reportable Ranges are reset to factory...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0926-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-12
Posted: 2018-03-08
Terminated: 2018-08-23
Recalling firm: Abbott Medical
Product: i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action Ranges, and Custom Reportable Ranges are reset to factory default values. No erroneous results are generated as a result of this issue.
Root cause tag: design
FDA root cause: Device Design
Action: The following actions are recommended if you have already upgraded to version 2.8: 1. If you are using Location, Operator, or Patient lists. a. Delete the following files: i. C:\Istat32\LocInstData\LocInstData.txt ii. C:\Istat32\OpData\OpData.txt iii. C:\Istat32\PatData\PatData.txt iv. C:\Istat32\Log\iSTATDMI Errors.txt v. All files named C:\Istat32\Log\DeCustLogXX.txt; where XX is any two digits. b. Stop and restart the DECOMSRV service, which in turn restarts the DEDPSRV service. 2. If you are using customized Reference Ranges, Action Ranges, and Custom Reportable Ranges: a. Open DE Customization Workspace. b. For each profile, select preferences by clicking the button with the profile name. c. Navigate to the Results tab. d. Verify the Action and Custom Reportable Ranges. Click Edit to make changes. e. If changes are made, click the OK button to save. If you have not upgraded to i-STAT/DE version 2.8, make arrangements with your data management vendor to update to the newer version of i-STAT/DE at your earliest opportunity. DO NOT UPGRADE without coordinating with your data management vendor so that continuity of your i-STAT testing is not impacted. How should you verify what version of i-STAT/DE is installed on a computer? Using the Program and Features app in Windows is the best way to determine the version of i-STAT/DE installed on your system. To do so, follow these steps: 1. Open Control Panel and the Program and Features applet. 2. Locate the program named i-STAT/DE Version 2.8 in the list. 3. The version column will show 2.8 for the old version and 2.8.0.1 for the new version. If you determine the version 2.8.0.1 is not installed, make arrangements with your data management vendor to update to the latest validated version compatible with your data management system. Enclosed is an updated i-STAT/DE version 2.8, version qualifier, 2.8.0.1 CD-ROM and a Business Reply Card (BRC). Please complete and return the Business Reply c
Quantity in commerce: 894
Distribution: Distributed in 48 States: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, Australia, Italy, Sweden, and Canada.
Product codes and lots: All units that have been upgraded to software version 2.8

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0926-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0926-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-08

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)