Z-1639-2022Class II

AggreGuide A-100 Instrument

Name: Z-1639-2022 AggreGuide A-100 Instrument
Creator: Aggredyne, Inc.
Published: 2019-07-23
License: https://open.fda.gov/license/

Aggredyne, Inc. / initiated 2019-07-23 / Completed / root cause: software

FDA source

Aggredyne, Inc. began a recall of AggreGuide A-100 Instrument on 2019-07-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-1639-2022
Classification: Class II
Status: Completed
Initiated: 2019-07-23
Posted: 2022-08-26
Recalling firm: Aggredyne, Inc.
Product: AggreGuide A-100 Instrument
Product code: JOZ System, Automated Platelet Aggregation
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.
Root cause tag: software
FDA root cause: Software design
Action: On 7/23/2019, a Service Bulletin was sent to distributors and users informing them to follow the User Manual, which states: 1) To shut down the instrument: Press the Shut Down button and wait. 2) Continue to wait for the screen message stating that it is safe to turn off your computer (this may take 15 seconds or more). 3) Turn off power switch only after the message "It is now safe to turn off your computer" is displayed. 4) A future communication from the recalling firm will be provided when the software update is available. On 7/8/22 updated Service Bulletin was sent to the distributor notifying them the software update was available. Field technicians will upgrade affected devices with software version 5.2.1.1.
Quantity in commerce: 47
Distribution: International distribution to the country of South Korea.
Product codes and lots: UDI-DI: 00856893004065; Software Versions 5.1 or 5.2; Serial Numbers Between xx0001 and xx0160

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1639-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1639-2022	Class II	Completed	Voluntary: Firm initiated	2022-09-07	2022-08-26

Product code JOZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)