FDA Device recall Z-1639-2022
AggreGuide A-100 Instrument
- FDA Device
- Class II
- completed
- Published 2022-09-07
On 2022-09-07 the FDA classified a Class II recall of AggreGuide A-100 Instrument by Aggredyne, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1639-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-07-23 |
| Published | 2022-09-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aggredyne |
| Distribution | n/a |
Product
AggreGuide A-100 Instrument
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 .
Identifiers
| code_info | UDI-DI: 00856893004065; Software Versions 5.1 or 5.2; Serial Numbers Between xx0001 and xx0160 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1639-2022%22
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