The Recall Desk
HighFDA (Devices)·Z-0268-2023·Announced 2022-11-30

Diagnostic System Software Defects Affecting Sample Processing and Test Accuracy

Abbott is recalling 883 Alinity m diagnostic systems due to software defects affecting sample identification, system operation, and test calibration. The issues affect all serial numbers running software version 1.6.5.

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 recall with software defects affecting diagnostic accuracy and system operation. No illnesses or injuries have been reported. The defects represent risk-of-harm potential (sample misidentification, calibration errors affecting test results), but per rubric criteria, the absence of reported illness limits the score to a maximum of 3.

Plain-English summary

Abbott Molecular, Inc. is recalling 883 Alinity m diagnostic systems (all serial numbers) due to identified software defects in version 1.6.5. The Alinity m System is an in vitro diagnostic device used in laboratory testing.

Four software defects have been identified. The system may fail to open the waste chute flapper when the Systems Solution drawer is closed and locked if the flapper has been moved out of position. The system may use incorrect barcode information from sample preparation drawer #1 when scanning drawer #2 barcode data before the previous scan is sent to the System Control Center. Under certain conditions when processing tests and new requests are made, if solution levels are too low, the system may error and leave reaction vessels in the Amplification Detection Unit instead of moving them to waste, blocking further processing. Additionally, the system may allow users to run replicate calibrations using two different lots of calibrator material without detection, creating calibration curves based on mixed material lots instead of a single lot as designed.

These systems were distributed worldwide. Users of affected systems should contact Abbott Molecular to determine if their system is affected and obtain guidance on the available remedial actions. Do not discontinue use of the device without consulting with Abbott and considering patient testing needs.

The recalled product

Product
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Manufacturer
Abbott Molecular, Inc.
Category
Medical Device — Diagnostic Equipment
Hazard
  • software-defect
  • sample-misidentification
  • calibration-error
  • diagnostic-inaccuracy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers

Distribution

Distribution scope not specified by the agency.

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