# FDA recall Z-0749-2022

> **Abbott Laboratories, Inc** · Class II · device recall initiated 2022-02-03.

## Product

Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479    The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.

## Reason for recall

Software error associated with the immunoassay analyzer wash cycle which is  using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.

## Distribution

Worldwide distribution: US (nationwide) including states of: AL, CA, GA, IL, IN, MN, MO, NC, OK, PA, RI, SC, TN, TX, WA, WI, MD and countries (OUS) including of: Australia, Austria, Bahrain, Belgium, Brazil, china, Colombia, Croatia, Cyprus, Czech Republic, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan Kuwait and Mexico.

## Key facts

- **Recall number:** Z-0749-2022
- **Recalling firm:** Abbott Laboratories, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-03
- **Report date:** 2022-03-23

- **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-0749-2022

## Citation

> AI Analytics. FDA recall Z-0749-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0749-2022. Source: US FDA. Licensed CC0.

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