AggreGuide A-100 Instrument

Recall Insight

This FDA Devices action (record #Z-1639-2022) was formally reported on September 7, 2022, with the manufacturer initiating the action on July 23, 2019. It is classified under Moderate severity (Class II), with a current status of Completed. Aggredyne, Inc. is listed as the recalling firm, operating out of Houston, TX. Federal records indicate 47 units are affected.

The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: International distribution to the country of South Korea.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.