DeviceClearance

Recall Z-1639-2022— Aggredyne, Inc.

Class II · Completed

Class II FDA medical device recall by Aggredyne, Inc., initiated 2019-07-23. It names 3 FDA 510(k) clearances: K181777, K163274, K122162. Product: AggreGuide A-100 Instrument. Reason: 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..

Recalling firm
Aggredyne, Inc.
Classification
Class II
Status
Completed
Initiated
2019-07-23
Firm location
Houston, TX, United States

510(k) clearances named in this recall

3 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.