Z-1580-2020Class II

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

Name: Z-1580-2020 LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01)...
Creator: Abbott Gmbh & Co. KG
Published: 2020-01-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-01-24 / Terminated / root cause: software

FDA source

Abbott Gmbh & Co. KG began a recall of 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)... on 2020-01-24. FDA classified it as Class II and gives the reason as "Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1580-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-24
Posted: 2020-03-26
Terminated: 2023-08-08
Recalling firm: Abbott Medical
Product: 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 code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
Root cause tag: software
FDA root cause: Software design
Action: The firm initiated the recall letter on January 24, 2020. The "Product Correction, Urgent - Immediate Action Required" notice identified the correction of the Alinity ci-series Software version 2.6.2 and earlier due to potential performance issues. the notice informed that Abbott is releasing Alinity ci-series Software version 3.1.0 to correct the issues. The notice provided the necessary actions required to be performed until the mandatory upgrade to SW 3.1.0 is complete. The notice referenced that details are included in table1 below. the notice detail that an Abbott representative will schedule a mandatory upgrade of your Alinity ci-series to software version 3.1.0. The notice also informed the customer if you have forwarded the product listed above to other laboratories, please inform them of the Product Correction and provide them a copy of this letter. The notice further instructs the customer to please retain this letter for your laboratory records The notice instructed the customers to please Abbott's Customer Service at 1 877 4ABBOTT(available 24 hours a day, 7 days a week). For customers outside the U.S., to please contact your local area Customer Service.
Quantity in commerce: 2676 units
Distribution: 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.
Product codes and lots: LN 3R70-01; software version 2.6.2 and earlier.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1580-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1580-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-26

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)