Company: Abbott Gmbh & Co. KG
Date of Enforcement Report: 4/1/2020
Class II
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.
- Recall Number: Z-1580-2020
REASON
Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
RECALLING FIRM/MANUFACTURER
Abbott Gmbh & Co. KG on 1/24/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2676 units
DISTRIBUTION
US Nationwide and International