PlainRecalls
FDA Devices Moderate Class II Completed

AggreGuide A-100 Instrument

Reported: September 7, 2022 Initiated: July 23, 2019 #Z-1639-2022

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.

Details

Recalling Firm
Aggredyne, Inc.
Units Affected
47
Distribution
International distribution to the country of South Korea.
Location
Houston, TX

Frequently Asked Questions

What product was recalled? ▼
AggreGuide A-100 Instrument. Recalled by Aggredyne, Inc.. Units affected: 47.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1639-2022.

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