Roche Diagnostics Corp.: VetLyte ISE Fluid Pack Recalled for Defective Seam and Inaccurate Results

Agency Publication Date: March 22, 2005

Summary

Roche Diagnostics Corp. is recalling approximately 86,479 units of the ISE-Electrolyte Systems VetLyte ISE Fluid Pack used in veterinary clinics. These fluid packs, manufactured for IDEXX Laboratories, may have a defective seam in their internal two-chamber pouch that allows chemical reagents to mix prematurely. This defect can prevent the VetLyte electrolyte analyzer from calibrating correctly or, more critically, cause the device to provide inaccurate (biased) test results for animal patients.

Risk

The mixing of reagents due to the faulty pouch seam can lead to incorrect electrolyte measurements in animals. This poses a risk of misdiagnosis or improper treatment decisions by veterinary professionals based on biased data.

What You Should Do

Identify your product by checking for the VetLyte ISE Fluid Pack, product number 98-05318-00, which was manufactured for IDEXX Laboratories, Inc.
Check the recall number V-081-5 and verify if your current stock of fluid packs shows any signs of leaking or failure to calibrate on your VetLyte analyzer.
Immediately stop using any fluid packs that fail calibration or appear to have compromised internal pouches.
Contact your healthcare provider, the manufacturer (Roche Diagnostics Corp.), or IDEXX Laboratories for further instructions and to discuss a potential refund or replacement.
For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

Other Action

Manufacturer contact for veterinary device

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

Affected Products

Product: ISE-Electrolyte Systems VetLyte ISE Fluid Pack

Model:

98-05318-00

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 30722

Status: Active

Manufacturer: Roche Diagnostics Corp.

Sold By: IDEXX Laboratories, Inc.

Manufactured In: United States

Units Affected: 86479 units.

Distributed To: Nationwide

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

Summary

What You Should Do

Identify your product by checking for the VetLyte ISE Fluid Pack, product number 98-05318-00, which was manufactured for IDEXX Laboratories, Inc.

Check the recall number V-081-5 and verify if your current stock of fluid packs shows any signs of leaking or failure to calibrate on your VetLyte analyzer.

Immediately stop using any fluid packs that fail calibration or appear to have compromised internal pouches.

Contact your healthcare provider, the manufacturer (Roche Diagnostics Corp.), or IDEXX Laboratories for further instructions and to discuss a potential refund or replacement.

For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.