Stop using now Medical device recall · FDA · Published October 2, 2023

Stanbio Recalls STAT-Site M BHB Test Strips Due to False Negative Risk

Stanbio Laboratory recalls specific lots of STAT-Site M BHB test strips due to stability issues that may cause false negative results for blood ketone levels.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0490-2024Medical device Stanbio Laboratory ›

Stop using this now

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.

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Contact the company

Recalling firmStanbio Laboratory, LP1261 N Main St · Boerne, TX 78006-3014

✎ GovInfoNow plain-language explainer

Stanbio Laboratory, LP is recalling STAT-Site M BHB Test Strips because deterioration in the strips' stability can lead to diminished detection capability at low ranges. This defect may result in false negative readings, which could delay necessary treatment for serious conditions like diabetic ketoacidosis. The recall affects 2,351 units distributed nationwide and internationally. Read more at govinfonow.com/recall/57185-stanbio-stat-site-m-bhb-test-strips-recall-false-negatives.

Source Summary by GovInfoNow · govinfonow.com/recall/57185-stanbio-stat-site-m-bhb-test-strips-recall-false-negatives · Updated October 13, 2026 · FDA enforcement record: FDA #Z-0490-2024

Cite this page

“Stanbio Recalls STAT-Site M BHB Test Strips Due to False Negative Risk.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/57185-stanbio-stat-site-m-bhb-test-strips-recall-false-negatives. Based on FDA recall #Z-0490-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0490-2024%22&limit=1).

The FDA announced on 2023-10-02 that Stanbio Laboratory, LP is recalling STAT-Site M BHB Test Strips due to stability deterioration that may cause false negative results. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Stanbio Laboratory
Product: STAT-Site M BHB Test Strips
UDI-DI: 00657498000090
Lot/Expiration: 203044/2024-01-31
Lot/Expiration: 209644/2024-06-30

The hazard

The deterioration in the stability of the Test Strips results in diminished low-range detection capability and an inability to meet linearity performance claims. This defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.

Context

GovInfoNow's records show Stanbio Laboratory, LP has 4 other recalls on record since 2018-02-08. Other recent recalls include the 2022-03-16 Stanbio Creamatocrit Plus recall for erroneous breast milk results and the 2021-07-12 Stanbio Synchron CX/DX/L recall for beta-hydroxybutyrate reagents that may give false low results. Other recent recalls of similar products include Vivoo Test Strips Recall (2025-11-22), Vivoo pH Test Recall (2025-11-22) and Vivoo Protein Test Recall (2025-11-22).

How to tell if you have this one

Check if you have STAT-Site M BHB Test Strips with UDI-DI 00657498000090. Specifically look for Lot numbers 203044 (expiration 2024-01-31) or 209644 (expiration 2024-06-30). These were sold in the US, Canada, and Singapore.

Brand
Stanbio Laboratory
Category
Medical device

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 35 states.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Dakota, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

Oct 2, 2023Firm started the recall
Dec 6, 2023FDA classified it Class II
Dec 13, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where were these products sold?

Distribution was worldwide, including US nationwide distribution and countries like Canada and Singapore.

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Link to this recall

<a href="https://govinfonow.com/recall/57185-stanbio-stat-site-m-bhb-test-strips-recall-false-negatives">Stanbio Recalls STAT-Site M BHB Test Strips Due to False Negative Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0490-2024 (October 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0490-2024 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.