Summary
The FDA issued a Class II for AggreGuide A-100 Instrument by Aggredyne, Inc.. Reason: The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software vers.
Details
Source
Device Recall
External ID
Z-1639-2022
Action Date
2022-09-07
Status
Completed
Category
device
Product Description
AggreGuide A-100 Instrument
Lot/Code Info: UDI-DI: 00856893004065; Software Versions 5.1 or 5.2; Serial Numbers Between xx0001 and xx0160
Quantity Affected: 47
Reason for Recall
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 .
Distribution
International distribution to the country of South Korea.
Type: Voluntary: Firm initiated
Recall Initiated: 2019-07-23
Company
Houston, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aggredyne, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aggredyne, Inc. have FDA actions?
This is the only FDA action we have on record for Aggredyne, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1639-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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