Abbott Gmbh & Co. KG: Medical Device Recall in 2020 - (Recall #: Z-1580-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 24, 2020

Date Posted: April 1, 2020

Recall Number: Z-1580-2020

Event ID: 84831

Reason for Recall:

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

Status: Terminated

Product Quantity: 2676 units

Code Information:

LN 3R70-01; software version 2.6.2 and earlier.

Distribution Pattern:

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, Botswana, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Madagascar, Malaysia, Mexico, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago Turkey, UEA, UK, Ukraine, Uruguay, Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated