AggreGuide A-100 Instrument — Class II medical device recall Z-1639-2022
Completed recall by Aggredyne, Inc., reported 2022-09-07. The firm identified a software design issue where the improper shut down of the instrument resulted in speeds
| Recall number | Z-1639-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aggredyne, Inc., Houston, TX, United States |
| Recall initiated | 2019-07-23 |
| Classified | 2022-08-26 |
| Reported by FDA | 2022-09-07 |
| Countries outside the US | KR |
| Quantity | 47 |
| Reason classes | potency, software |
| UPC / GTIN / UDI-DI | 00856893004065 |
Product
AggreGuide A-100 Instrument
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 .
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1639-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.