Abbott Point Of Care Inc. recalls i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 0005…

Recall date

September 12, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0926-2018

FDA classification

Class II

Brand / firm

Abbott Point Of Care Inc.

Sold / distributed

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.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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