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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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