---
title: "Alinity m System. The Alinity m System is designed to automate the steps for ... — FDA record Z-1009-2023 | Is It on Recall"
description: "The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADU"
url: https://isitonrecall.com/recall/fda-device-z-1009-2023-alinity-m-system-the-alinity-m-system-is-designed-to-automate-the-steps-for-nucleic-acid-testing-whi/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sam... — FDA record Z-1009-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 9, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
- **Reason**: The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.
- **Classification**: Class II
- **Recalling firm**: Abbott Molecular, Inc.
- **Quantity**: 918 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1009-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1009-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model Number: 08N53-002 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

x

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Feb 1, 2023
- **Recall initiation date**: Dec 9, 2022
- **Center classification date**: Jan 20, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1009-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Abbott Molecular, Inc. records](https://isitonrecall.com/brand/abbott-molecular-inc/)