RecallRadar

FDA Device recall Z-1580-2020

LN 3R70-01

On 2020-04-01 the FDA classified a Class II recall of LN 3R70-01 by Abbott And Kg, citing abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1580-2020
ClassificationClass II
Statusterminated
Initiated2020-01-24
Published2020-04-01
Last updated2026-09-13 11:55 UTC
CompanyAbbott And Kg
DistributionUS

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.

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1580-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.