---
title: "The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. — FDA record Z-1518-2022 | Is It on Recall"
description: "Incorrect optical calibration"
url: https://isitonrecall.com/recall/fda-device-z-1518-2022-the-alinity-m-system-ref-08n53-002-for-in-vitro-diagnostic-use/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. — FDA record Z-1518-2022

Reported completed

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 Jul 19, 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**: The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
- **Reason**: Incorrect optical calibration
- **Classification**: Class II
- **Recalling firm**: Abbott Molecular, Inc.
- **Quantity**: 1
- **Agency-reported status**: Completed
- **Source record identifier**: Z-1518-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1518-2022%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 | Serial Number 00654 |

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

## Distribution

There was only foreign distribution to Italy.

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

## Dates in the source

- **Report date**: Aug 24, 2022
- **Recall initiation date**: Jul 19, 2022
- **Center classification date**: Aug 12, 2022

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-1518-2022%22)

## Related records

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