# FDA recall Z-1009-2023

> **Abbott Molecular, Inc.** · Class II · device recall initiated 2022-12-09.

## 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 for recall

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.

## Distribution

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## Key facts

- **Recall number:** Z-1009-2023
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-09
- **Report date:** 2023-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Des Plaines, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1009-2023

## Citation

> AI Analytics. FDA recall Z-1009-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1009-2023. Source: US FDA. Licensed CC0.

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