AggreGuide A-100 Instrument
Check against the official notice below — it lists the full affected range.
Aggredyne, Inc. is recalling the AggreGuide A-100 Instrument due to a software design issue affecting 47 units distributed to South Korea. When the instrument shuts down improperly, the software's speeds.csv file is erased, causing the target RPM and motor output to reset to 0. This results in the motor receiving 0 volts and performing a 0 RPM assay.
Because the motor does not run, the blood sample is not mixed with agonist and aggregates do not move in front of the optical detectors. This causes the assay result to display as "Low" with a PAI value of 0, which does not accurately reflect the true test results. The recall affects AggreGuide A-100 instruments with software versions 5.1 or 5.2 and serial numbers between xx0001 and xx0160. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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 .
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. Quantity: 47 Lot/code info: UDI-DI: 00856893004065; Software Versions 5.1 or 5.2; Serial Numbers Between xx0001 and xx0160
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.