# FDA recall Z-1009-2022

> **MESA BIOTECH, INC** · Class I · device recall initiated 2022-04-06.

## Product

Accula SARS-CoV-2 Test, REF: COV4100

## Reason for recall

SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.

## Distribution

US Nationwide distribution in the states of CA, TX, MA, NY, FL, NC, NJ, GA, CO, HI, PA, WA, NY, VA, MD, KY, WI, IL, PR, ND, MI, TN, AZ, UT.

## Key facts

- **Recall number:** Z-1009-2022
- **Recalling firm:** MESA BIOTECH, INC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-06
- **Report date:** 2022-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1009-2022

## Citation

> AI Analytics. FDA recall Z-1009-2022. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1009-2022. Source: US FDA. Licensed CC0.

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