# FDA recall Z-0940-2021

> **Biomeme, Inc.** · Class III · device recall initiated 2021-01-05.

## Product

Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler has a "baseboard" unit with firmware and associated software component that control motorized movements of the optical filter carriage used for PCR detection.

## Reason for recall

Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.

## Distribution

Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD.   Foreign: Canada, Zimbabwe.

## Key facts

- **Recall number:** Z-0940-2021
- **Recalling firm:** Biomeme, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-05
- **Report date:** 2021-02-10
- **Termination date:** 2021-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Philadelphia, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0940-2021

## Citation

> AI Analytics. FDA recall Z-0940-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0940-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*