Recall- Software Design Issue Leads to Critical Data Errors

Company: Aggredyne, Inc.
Date of Enforcement Report: 8/26/2022
Class II

PRODUCT

AggreGuide A-100 Instrument

Recall Number:

Z-1639-2022

REASON

The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this issue, the target RPM for the assay is 0 and the motor output required to achieve this RPM is also 0. Therefore, when the assay is run, the software applies 0 Volts to the motor and performs a 0 RPM assay. Because of this, there is no mixing of the blood with agonist and no moving of aggregates happens in front of the optical detectors. The resulting PAI is 0 and the result is displayed as Low.

RECALLING FIRM/MANUFACTURER

Aggredyne, Inc.

VOLUME OF PRODUCT IN COMMERCE

47

DISTRIBUTION

International distribution to the country of South Korea.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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