Recall – Probe wash system software error leads to unexpected events

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

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