# FDA recall Z-0655-2021

> **Hardy Diagnostics** · Class II · device recall initiated 2020-10-23.

## Product

Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD,      CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents

## Reason for recall

There is a potential for contamination within Viral  Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.

## Distribution

US Nationwide Distribution: CA, NC, AK, NY, OH, IL, NC, WI, SD, FL, DE, MI, MA, MD, GA, , TX, PA, IA, WV, ID, UT, KS, OR, CT, NY, WA, VA, TN, HI, AL, KY, MN, PR, MO, WI, AZ, SC, LA, AR, IN, NE, MS, NH, and OK.

## Key facts

- **Recall number:** Z-0655-2021
- **Recalling firm:** Hardy Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-23
- **Report date:** 2020-12-30
- **Termination date:** 2022-09-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Maria, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0655-2021

## Citation

> AI Analytics. FDA recall Z-0655-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0655-2021. Source: US FDA. Licensed CC0.

---

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