Abbott i-STAT DE Software Version 2.8 Recall: Data Not Updating Correctly
Abbott recalls i-STAT DE handheld data processing modules with software version 2.8. These units may not update patient lists or custom reference ranges, but do not cause erroneous results.
Lower-risk 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.
Contact the company
What happened, in plain English
Abbott is recalling i-STAT DE handheld data processing modules that have been upgraded to software version . This issue means patient lists and custom reference ranges may not update correctly, but the device does not generate incorrect results. Read more at govinfonow.com/recall/73038-abbott-i-stat-de-software-version-2-8-recall-data.
Source Summary by GovInfoNow · govinfonow.com/recall/73038-abbott-i-stat-de-software-version-2-8-recall-data · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0926-2018
Cite this page
“Abbott i-STAT DE Software Version 2.8 Recall: Data Not Updating Correctly.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73038-abbott-i-stat-de-software-version-2-8-recall-data. Based on FDA recall #Z-0926-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0926-2018%22&limit=1).
Why it’s dangerous
The software update causes patient lists and custom reference ranges to reset to factory defaults. This means any custom settings made by healthcare providers may not be retained after the update. However, the device does not produce incorrect test results.
Who’s affected
Healthcare professionals using the i-STAT DE device with software version 2.8 are affected. Those who rely on custom reference ranges for patient testing are at slightly higher risk.
How to tell if you have this one
Check if your i-STAT DE device has software version 2.8. The recall applies to all units upgraded to this specific software version.
- Brand
Abbott- Category
Medical device
What to do — step by step
Check Software Version
Verify your i-STAT DE device's software version. If it is 2.8, it is affected by this recall.
Where it went and when
Where it was distributed
Distributed in 48 states and D.C., and outside the U.S.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0926-2018 (September 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0926-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.