Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
i-STAT DE handheld data processing module for clinical use Recalled by Abbott Point Of Care Inc. Due to Issues resulting from upgrade to software version 2.8:...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Point Of Care Inc. directly.
Affected Products
i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
Quantity: 894
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 48 states: AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY
About Abbott Point Of Care Inc.
Abbott Point Of Care Inc. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report