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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Mckesson Medical-Surgical Inc. Corporate Office: Quantimetrix Dipper Urinalysis Dipstick Control Recalled for Temperature Exposure

Agency Publication Date: October 22, 2024
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Summary

McKesson Medical-Surgical Inc. has recalled one box of its Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 (6 X 15 mL). The product was shipped without the necessary summer packaging required to maintain safe temperatures and may have been exposed to heat above 25°C (77°F). This exposure can degrade the product, potentially causing inaccurate test results or delays in a patient receiving their medical diagnosis. This specific unit was distributed in Washington, D.C.

Risk

Exposure to temperatures above 25°C can compromise the chemical integrity of the urinalysis control material. Using a degraded control could lead to incorrect laboratory readings, which may cause healthcare providers to delay or misinterpret patient urinalysis results.

What You Should Do

  1. Identify your product by checking the packaging for the name 'Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2' in the 6 X 15 mL size.
  2. Verify the Unique Device Identifier (UDI-DI) number 896863002134 and Recall Number Z-0138-2025 on your supply records or packaging to confirm your unit is affected.
  3. If you have the affected product, contact your healthcare provider or McKesson Medical-Surgical Inc. immediately to determine if the product is safe to use or if a replacement is required.
  4. Contact McKesson Medical-Surgical Inc. at their corporate office for further instructions regarding a potential refund or replacement for the compromised unit.
  5. For additional questions or to report issues, 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

Manufacturer and Healthcare Consultation

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

Affected Products

Product: Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 (6 X 15 mL)
Model / REF:
Recall #: Z-0138-2025
UPC Codes:
896863002134

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95410
Status: Active
Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office
Sold By: McKesson Medical-Surgical Inc.
Manufactured In: United States
Units Affected: 1 BOX
Distributed To: District of Columbia

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.