Stanbio Laboratory, LP: STAT-Site M BHB Test Strips Recalled for Inaccurate Results

Agency Publication Date: December 6, 2023

Summary

Stanbio Laboratory is recalling 2,351 units of STAT-Site M BHB Test Strips, which are used with a specific meter to measure blood ketone levels. These strips may provide false negative results or inaccurate low-range readings due to a manufacturing defect that caused the chemical coating on the strips to deteriorate. This defect can lead to serious delays in medical treatment for patients with conditions such as diabetic ketoacidosis. Consumers should contact their healthcare provider or the manufacturer immediately for guidance.

Risk

The test strips may fail to accurately detect ketones in the blood, potentially providing a false negative result that indicates a patient is healthy when they are actually in a dangerous medical state. This can lead to a significant delay in life-saving treatment for diabetic ketoacidosis, a life-threatening complication of diabetes.

What You Should Do

Locate your STAT-Site M BHB Test Strip packaging and check for the following identifying information: UDI-DI 00657498000090.
Check the lot and expiration details on your package: verify if you have Lot 203044 with an expiration date of 2024-01-31, or Lot 209644 with an expiration date of 2024-06-30.
If your test strips match these lot numbers and expiration dates, contact your healthcare provider or physician immediately to discuss alternative testing methods and your clinical care.
Contact the manufacturer, Stanbio Laboratory, LP, at their Boerne, Texas facility or through their customer service channels to report your affected product and receive further instructions on replacements or returns.
For additional questions or to report adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Consult healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: STAT-Site M BHB Test Strips

Model / REF:

UDI-DI: 00657498000090

Lot Numbers:

203044 (Exp 2024-01-31)

209644 (Exp 2024-06-30)

Date Ranges: Expiration: 2024-01-31, Expiration: 2024-06-30

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93300

Status: Active

Manufacturer: Stanbio Laboratory, LP

Sold By: Nationwide distributors

Manufactured In: United States

Units Affected: 2,351

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

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Locate your STAT-Site M BHB Test Strip packaging and check for the following identifying information: UDI-DI 00657498000090.

Check the lot and expiration details on your package: verify if you have Lot 203044 with an expiration date of 2024-01-31, or Lot 209644 with an expiration date of 2024-06-30.

If your test strips match these lot numbers and expiration dates, contact your healthcare provider or physician immediately to discuss alternative testing methods and your clinical care.

Contact the manufacturer, Stanbio Laboratory, LP, at their Boerne, Texas facility or through their customer service channels to report your affected product and receive further instructions on replacements or returns.

For additional questions or to report adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.