Aggredyne, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1639-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

AggreGuide A-100 Instrument

Product Classification:

Class II

Date Initiated: July 23, 2019

Date Posted: September 7, 2022

Recall Number: Z-1639-2022

Event ID: 90588

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.

Status: Completed

Product Quantity: 47

Code Information:

UDI-DI: 00856893004065; Software Versions 5.1 or 5.2; Serial Numbers Between xx0001 and xx0160

Distribution Pattern:

International distribution to the country of South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated