Home / Recalls / Aggredyne, Inc. / Z-1639-2022

Z-1639-2022 Class II

Recalled by Aggredyne, Inc. — Houston, TX

Recall Details

Product Type: Devices
Report Date: September 7, 2022
Initiation Date: July 23, 2019
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 47

Product Description

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 Pattern

International distribution to the country of South Korea.

Code Information

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