Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.