# FDA recall Z-2202-2021

> **Stanbio Laboratory, LP** · Class III · device recall initiated 2021-07-12.

## Product

Cardinal Health Beta-Hydroxybutyrate .  in vitro diagnostic reagent.

## Reason for recall

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of  Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.

## Key facts

- **Recall number:** Z-2202-2021
- **Recalling firm:** Stanbio Laboratory, LP
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-12
- **Report date:** 2021-08-11
- **Termination date:** 2022-03-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boerne, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2202-2021

## Citation

> AI Analytics. FDA recall Z-2202-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2202-2021. Source: US FDA. Licensed CC0.

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