Abbott Point Of Care Inc.: Medical Device Recall in 2018 - (Recall #: Z-0926-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 12, 2017

Date Posted: March 14, 2018

Recall Number: Z-0926-2018

Event ID: 79150

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.

Status: Terminated

Product Quantity: 894

Code Information:

All units that have been upgraded to software version 2.8

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated