Recall – Probe wash system software error leads to unexpected events

Company: Abbott Laboratories, Inc
Date of Enforcement Report: 10/16/2019
Class II


Alinity S System, Part Number 06P16-01

  • Recall Number: Z-0111-2020


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.


Abbott Laboratories, Inc on 8/30/2019. Voluntary:  Firm Initiated recall is ongoing.


27 Alinity S Systems



Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.