# FDA recall Z-0958-2023

> **Abbott Laboratories** · Class III · device recall initiated 2022-11-24.

## Product

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

## Reason for recall

Reaction vessels may contain a potential contaminant that could affect their optical performance.

## Distribution

US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV

## Key facts

- **Recall number:** Z-0958-2023
- **Recalling firm:** Abbott Laboratories
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-24
- **Report date:** 2023-01-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0958-2023

## Citation

> AI Analytics. FDA recall Z-0958-2023. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0958-2023. Source: US FDA. Licensed CC0.

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