FDA Medical Device Recalls (openFDA)
Aggredyne, Inc.: AggreGuide A-100 Instrument
- Recall number
- Z-1639-2022
- Recalling firm
- Aggredyne, Inc.
- Product
- AggreGuide A-100 Instrument
- Status
- Completed
- Initiated
- 2019-07-23
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- Software design
- 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.
- Quantity
- 47
- Distribution
- International distribution to the country of South Korea.
- Lot, serial or model codes
- UDI-DI: 00856893004065; Software Versions 5.1 or 5.2; Serial Numbers Between xx0001 and xx0160
- 510(k) numbers
- ["K122162","K163274","K181777"]
- PMA numbers
- not on file
- Product code
- JOZ
- Firm FEI
- 3009610394
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28