# FDA recall Z-0884-2022

> **Abbott Molecular, Inc.** · Class II · device recall initiated 2022-03-04.

## Product

Alinity m HBV AMP Kit (US and CE)

## Reason for recall

There is a potential for misquantitation high results for negative samples.

## Distribution

US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA    OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam

## Key facts

- **Recall number:** Z-0884-2022
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-04
- **Report date:** 2022-04-13

- **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-0884-2022

## Citation

> AI Analytics. FDA recall Z-0884-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0884-2022. Source: US FDA. Licensed CC0.

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