# FDA recall Z-0490-2024

> **Stanbio Laboratory, LP** · Class II · device recall initiated 2023-10-02.

## Product

STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

## Reason for recall

Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.

## Distribution

Worldwide - US Nationwide distribution including in the states of AZ, RI, MO, UT, AK, LA, TX, OH, GA, MN, NY, CA, NJ, IL, WA, KS, MI, NC, PA, MA, CO, KY, NM, FL, MD, VA, IN, AL, SD, MS, WV, WI, ID, MT, WY and the countries of Canada and Singapore.

## Key facts

- **Recall number:** Z-0490-2024
- **Recalling firm:** Stanbio Laboratory, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-02
- **Report date:** 2023-12-13

- **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-0490-2024

## Citation

> AI Analytics. FDA recall Z-0490-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0490-2024. Source: US FDA. Licensed CC0.

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