# FDA recall Z-0268-2023

> **Abbott Molecular, Inc.** · Class II · device recall initiated 2022-10-12.

## Product

Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

## Reason for recall

Abbott has identified potential performance issues for the Alinity m System software version 1.6.5:    1)	In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out of position.  2)	Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned.  3)	Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. An internal counter is reset which can cause reaction vessels (RVs) already present in an Amplification Detect

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0268-2023
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-12
- **Report date:** 2022-11-30

- **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-0268-2023

## Citation

> AI Analytics. FDA recall Z-0268-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0268-2023. Source: US FDA. Licensed CC0.

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