The Recall Desk
HighFDA (Devices)·Z-1639-2022·Announced 2022-09-07

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.

What this means for you

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.
Category
Medical Device — In Vitro Diagnostic / Blood Aggregation Testing
Hazard
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.

Related recalls

Same hazard · inaccurate test results

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