AggreGuide A-100 Instrument recall: Software Issue
AggreGuide A-100 Instrument
Why was AggreGuide A-100 Instrument recalled?
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 .
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00856893004065; Software Versions 5.1 or 5.2; Serial Numbers Between xx0001 and xx0160
- Product
- AggreGuide A-100 Instrument
- Recalling firm
- Aggredyne, Inc.
- Quantity
- 47
- Distribution
- International distribution to the country of South Korea.
- Recall date
- September 7, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)