# FDA recall Z-2276-2021

> **Abbott Laboratories, Inc** · Class II · device recall initiated 2021-07-12.

## Product

Alinity s System REF 06P16-01.   An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.

## Reason for recall

A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.

## Distribution

Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Mexico, Netherlands, Pakistan, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzania, United Arab Emirates, United Kingdom, Ukraine and Zimbabwe.

## Key facts

- **Recall number:** Z-2276-2021
- **Recalling firm:** Abbott Laboratories, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-12
- **Report date:** 2021-08-18

- **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-2276-2021

## Citation

> AI Analytics. FDA recall Z-2276-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2276-2021. Source: US FDA. Licensed CC0.

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