Abbott Gmbh & Co. KG recalls LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module…

Recall date

January 24, 2020

Source

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

Recall number

Z-1580-2020

FDA classification

Class II

Brand / firm

Abbott Gmbh & Co. KG

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, ID, IL, LA, MA, MD, ME, MI, MN, MC, MS, NC, NJ, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and countries of Albania, Argentina, Australia, Austria, Bahrain, Bangledesh, Belgium, Bermuda, Bosnia, Bot…

Why it was recalled

Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.

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

What was recalled

LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.