AggreGuide A-100 Instrument recallZ-1639-2022 · Aggredyne, Inc. · initiated Jul 23, 2019
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aggredyne, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1639-2022
- Status
- Completed
- Initiated by the company
- Jul 23, 2019
- Recalling firm
- Aggredyne, Inc.
- Quantity
- 47
- Product code
- JOZ
- FDA submissions
- K122162, K163274, K181777
- Distribution
- International distribution to the country of South Korea.
Product description
AggreGuide A-100 Instrument
Code information (models, lots, serial numbers)
UDI-DI: 00856893004065; Software Versions 5.1 or 5.2; Serial Numbers Between xx0001 and xx0160
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Aggreguide A-100Aggredyne, Inc. · System, Automated Platelet Aggregation1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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