FDAFDA · Food and drugs·Recall number Z-1580-2020
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.
Published April 1, 2020 · Recall initiated: January 24, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Gmbh & Co. KG
- Distributor
- 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.
- Lot
- LN 3R70-01; software version 2.6.2 and earlier.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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