# FDA recall Z-0452-2022

> **Biomeme, Inc.** · Class II · device recall initiated 2021-10-20.

## Product

Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824  Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564

## Reason for recall

The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies have indicated the need to shorten the life of the RPC Buffer once resuspended from the current instruction of one week to two days when stored at room temperature (15degC-30degC).

## Distribution

Domestic distribution to AZ, CA, FL, HI, IN, KY, MD, MO, NC, NJ, NY, OH, OK, PA, TX, VA. Foreign distribution to Ghana, Dominican Republic, and Singapore.

## Key facts

- **Recall number:** Z-0452-2022
- **Recalling firm:** Biomeme, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-20
- **Report date:** 2022-01-12
- **Termination date:** 2024-03-05

- **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-0452-2022

## Citation

> AI Analytics. FDA recall Z-0452-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0452-2022. Source: US FDA. Licensed CC0.

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