Aggredyne, Inc. recalls AggreGuide A-100 Instrument

Recall date

July 23, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1639-2022

FDA classification

Class II

Brand / firm

Aggredyne, Inc.

Sold / distributed

International distribution to the country of South Korea.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AggreGuide A-100 Instrument