Company: Abbott Laboratories, Inc
Date of Enforcement Report: 3/23/2022
Class II
PRODUCT
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.
Recall Number: Z-0749-2022
REASON
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc on 2/3/2022. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
306 units
DISTRIBUTION
U.S. Nationwide and International