The Recall Desk
HighFDA (Devices)·Z-0749-2022·Announced 2022-03-23

Abbott Alinity s System software error affects diagnostic analyzer wash cycle

Abbott Laboratories is recalling 306 units of Alinity s System software version 2.8.0 due to a software error causing insufficient wash buffer volume, which could affect diagnostic test accuracy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a software malfunction that could compromise diagnostic accuracy. No illnesses or injuries have been reported, but the hazard creates a risk of harm through potential test inaccuracy.

Plain-English summary

Abbott Laboratories is recalling 306 units of Alinity s System software version 2.8.0 (REF LN 06P16-01) used in clinical laboratories worldwide. The system is a fully automated immunoassay analyzer designed to detect the presence of specific antigens and antibodies in patient samples.

A software error in the wash cycle causes the system to use 1 milliliter of wash buffer instead of the intended 3 milliliters to clean the exterior of the probe. This insufficient washing could leave residual material on the probe, potentially compromising the accuracy of diagnostic test results.

The affected devices have serial numbers AS1001 through AS1387 and were distributed across the United States and multiple international countries including Australia, Austria, Brazil, China, Germany, Mexico, and others. Laboratory facilities using affected units should contact Abbott Laboratories for instructions on obtaining a corrective software update or system replacement to restore proper functionality.

The recalled product

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 specifi
Manufacturer
Abbott Laboratories, Inc
Category
Medical Device — In Vitro Diagnostic / Laboratory Analyzer
Hazard
  • software-error
  • diagnostic-inaccuracy

Distribution

Distributed nationwide across the United States.

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