AggreGuide A-100 Instrument
FDA Recall Z-1639-2022 · Posted None
Recalling FirmAggredyne, Inc.
Recall StatusCompleted
Product CodeJOZ
Date Initiated2019-07-23
Product Quantity47
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.
Firm Action
On 7/23/2019, a Service Bulletin was sent to distributors and users informing them to follow the User Manual, which states:
1) To shut down the instrument: Press the Shut Down button and wait.
2) Continue to wait for the screen message stating that it is safe to turn off your computer (this may take 15 seconds or more).
3) Turn off power switch only after the message "It is now safe to turn off your computer" is displayed.
4) A future communication from the recalling firm will be provided when the software update is available.
On 7/8/22 updated Service Bulletin was sent to the distributor notifying them the software update was available. Field technicians will upgrade affected devices with software version 5.2.1.1.
Root Cause
Software design
Distribution Pattern
International distribution to the country of South Korea.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.