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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 Vet
Medical Devices/Diagnostic Equipment

Arkray Factory USA, Inc.: Veterinary Glucose Test Strips Recalled for Incorrect Low Glucose Reports

Agency Publication Date: December 19, 2016
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Summary

Arkray Factory is recalling 4,780 boxes of Spotchem II Glucose and Spotchem II EZ Health Check Vet Multistrips used for veterinary diagnostic testing. These test strips are incorrectly reporting low blood glucose levels even when actual levels are above 265/dL. This defect can lead to incorrect treatment decisions for animals, as veterinary professionals may act on false low readings. Owners and veterinary clinics should contact the manufacturer immediately for further instructions and a potential refund or replacement.

Risk

The test strips provide inaccurate readings, specifically reporting dangerously low blood sugar levels when the actual level is high (above 265/dL). This could cause veterinary professionals to mismanage a pet's health, potentially administering glucose or adjusting insulin incorrectly based on false data.

What You Should Do

  1. Check your supply for Arkay SPOTCHEM II Glucose (25 strips) with any of the following lot codes: EA5A79, EA5F85, or EA5G86.
  2. Check your supply for Arkay SPOTCHEM II EZ Health Check Vet Multistrip [Panel-V] (25 strips) with any of the following lot codes: PL4L91, PL4M92, PL5A93, PL5B94, PL5C96, PL5E98, PL5G01, or PL5H02.
  3. Immediately stop using any test strips from the affected lot numbers and set them aside to prevent accidental use.
  4. Contact your veterinary healthcare provider or Arkray Factory USA, Inc. at their Minneapolis headquarters (5182 W 76th St, Minneapolis, MN 55439) for further instructions and potential product refund or replacement.
  5. Call the FDA's Center for Veterinary Medicine at 240-402-7002 if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer instruction following notification

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

Affected Products

Product: Arkay SPOTCHEM II Glucose (25 strips)
Model:
V-0041-2017
Lot Numbers:
EA5A79
EA5F85
EA5G86
Product: Arkay SPOTCHEM II EZ Health Check Vet Multistrip [Panel-V] (25 strips)
Model:
V-0042-2017
Lot Numbers:
PL4L91
PL4M92
PL5A93
PL5B94
PL5C96
PL5E98
PL5G01
PL5H02

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73834
Status: Resolved
Manufacturer: Arkray Factory USA, Inc.
Sold By: Veterinary clinics; Specialized veterinary distributors
Manufactured In: United States
Units Affected: 2 products (2390 boxes total for all products)
Distributed To: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, 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 ยท Raw API Response