Recall Z-2276-2021— Abbott Laboratories, Inc

Name: FDA recall Z-2276-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-12

Class II · Ongoing

Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2021-07-12. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators..

Recalling firm: Abbott Laboratories, Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-07-12
Firm location: Irving, TX, United States

Product description

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.

Reason for recall

A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.

Data sourced from openFDA. This site is unofficial and independent of the FDA.