Company: Abbott Laboratories, Inc
Date of Enforcement Report: 8/18/2021
Class II
PRODUCT
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
Recall Number: Z-2241-2021
REASON
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc on 7/12/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
260 systems
DISTRIBUTION
U.S. Nationwide and International