[pending] AggreGuide A-100 Instrument
Pending LLM rewrite. Source: FDA_DEVICE Z-1639-2022.
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: Pending LLM scoring against the rubric.
Plain-English summary
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 .
The recalled product
- Product
- AggreGuide A-100 Instrument
- Manufacturer
- Aggredyne, Inc.
- Category
- Medical Device — Devices
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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