AggreGuide A-100 Instrument Software Issue Affecting Test Results
Aggredyne, Inc. is recalling the AggreGuide A-100 Instrument due to a software design defect that causes the device to run assays at 0 RPM, resulting in no blood mixing and inaccurate test results displayed as Low.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall. Although no illnesses or injuries are explicitly reported in the source text, the defect causes inaccurate diagnostic test results (all results reported as Low), which creates a risk of harm through misdiagnosis and incorrect patient treatment decisions.
Plain-English summary
Aggredyne, Inc. is recalling the AggreGuide A-100 Instrument (UDI-DI: 00856893004065) with software versions 5.1 or 5.2 and serial numbers between xx0001 and xx0160. The device has been distributed internationally to South Korea.
The recall is due to a software design issue in which improper instrument shutdown erases the contents of the speeds.csv file. This causes the target RPM for the assay to be set to 0, and the motor output required to achieve this speed is also 0. When an assay is run, the software applies 0 Volts to the motor and performs a 0 RPM assay.
Because the motor does not run, there is no mixing of blood with agonist and no movement of aggregates in front of the optical detectors. This results in a platelet aggregation index (PAI) of 0, and the test result is displayed as Low, which does not reflect the actual patient sample.
Users of affected devices should contact Aggredyne, Inc. for guidance on device replacement or software corrections.
The recalled product
- Product
- AggreGuide A-100 Instrument
- Manufacturer
- Aggredyne, Inc.
- Affected units
- 47
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 00856893004065
- Software Versions 5.1 or 5.2
- Serial Numbers Between xx0001 and xx0160
Distribution
Distribution scope not specified by the agency.
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