Class 2 Device Recall AggreGuide A100 System

• Date Initiated by Firm: July 23, 2019
• Create Date: August 26, 2022
• Recall Status: Completed
• Recall Number: Z-1639-2022
• Recall Event ID: 90588
• 510(K)Number: K122162 K163274 K181777
• Product Classification: System, automated platelet aggregation - Product Code JOZ
• Product: AggreGuide A-100 Instrument
• Code Information: UDI-DI: 00856893004065; Software Versions 5.1 or 5.2; Serial Numbers Between xx0001 and xx0160
• FEI Number: 3009610394
• Recalling Firm/ Manufacturer: Aggredyne, Inc.; 10530 Rockley Rd Ste 150; Houston TX 77099-3574
• For Additional Information Contact: 713-636-5996
• Manufacturer 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 .
• FDA Determined 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 in Commerce: 47
• Distribution: International distribution to the country of South Korea.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• 510(K) Database: 510(K)s with Product Code = JOZ