FDA recall Z-1639-2022

Aggredyne, Inc. · Class II · device

Product

AggreGuide A-100 Instrument

Reason for recall

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.

Distribution

International distribution to the country of South Korea.

Key facts

Status: Completed
Initiation date: 2019-07-23
Report date: 2022-09-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1639-2022