Reported Sep 7, 2022 · Completed
AggreGuide A-100 Instrument
Aggredyne, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aggredyne, Inc. · 10530 Rockley Rd Ste 150 · Houston, TX · 77099-3574
Is this the product you have?
- AggreGuide A-100 Instrument
- Lot codes and dates
- UDI-DI
00856893004065Software Versions 5.1 or 5.2Serial Numbers Between xx0001 and xx0160
- UDI-DI
- Amount recalled
- 47
Why it was 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 .
This product could cause temporary or reversible health problems — stop using it.
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