Severity
Moderate
ModerateClass IICompleted
FDA Devices recall · Reported September 7, 2022
AggreGuide A-100 Instrument
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 …
Aggredyne, Inc. recalled AggreGuide A-100 Instrument - a moderate-severity action.
AggreGuide A-100 Instrument was recalled by Aggredyne, Inc. in September 7, 2022. Reason: The firm identified a software design issue where the improper shut down of the instrument resulted in speed…. Check the official notice for the remedy. Verify recall #Z-1639-2022 with the FDA Devices before acting.
The recall
Aggredyne, Inc. issued this moderate-severity FDA Devices recall-The firm identified a software design issue where the improper shut down of the instrument resulted in speed….
- Moderate
- severity level
- 47 units
- affected scope
- Class II
- classification
- September 7, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1639-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1639-2022) was formally reported on September 7, 2022, with the manufacturer initiating the action on July 23, 2019. It is classified under Moderate severity (Class II), with a current status of Completed. Aggredyne, Inc. is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 47.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: International distribution to the country of South Korea.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
47
Related Recalls
6
3 from same agency
Product description
AggreGuide A-100 Instrument
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 .
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-1639-2022 |
| Date reported | September 7, 2022 |
| Date initiated | July 23, 2019 |
| Recalling firm | Aggredyne, Inc. |
| Firm location | Houston, TX |
| Affected scope | 47 |
| Distribution | International distribution to the country of South Korea. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1639-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
AggreGuide A-100 Instrument. Recalled by Aggredyne, Inc.. Units affected: 47.
Why was this product 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 .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1639-2022.
Where was the recalled product distributed? ▼
Distribution: International distribution to the country of South Korea..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1639-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 7, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.