Company: Abbott Laboratories, Inc
Date of Enforcement Report: 10/16/2019
Class II
PRODUCT
Alinity S System, Part Number 06P16-01
- Recall Number: Z-0111-2020
REASON
Two software issues have been identified for the Alinity S System containing software version 2.0.0: Alinity’s Probe Wash: When Alinity’s CMV IgG Qualitative assay is run as the last assay on a sample, one of two unexpected events may occur: – An insufficient wash of the probe. The insufficient wash may compromise the following sample aspirated with that probe, potentially causing a false reactive result for any of the assays run. All other assays, when run in any position in a profile, have sufficient probe washes -The embedded software may shut down unexpectedly. This shutdown may be recovered in less than 8 hours. The operations manual provides instructions in the event of an unexpected shutdown.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc on 8/30/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
27 Alinity S Systems
DISTRIBUTION
International