Abbott Point Of Care Inc.: i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)

Recall number

Z-0926-2018

Recalling firm

Abbott Point Of Care Inc.

Product

i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)

Status

Terminated

Initiated

2017-09-12

Posted

not on file

Terminated

2018-08-23

Reason

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

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

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.

Lot, serial or model codes

All units that have been upgraded to software version 2.8

510(k) numbers

not on file

PMA numbers

not on file

Product code

JQP

Firm FEI

2245578

Firm city

Princeton

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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