Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Macherey Nagel Gmbh & Co. Kg: Urispec 11-Way Reagent Test Strips Recalled for False Negative Risk

Agency Publication Date: May 16, 2024
Share:
Sign in to monitor this recall

Summary

Macherey Nagel Gmbh & Co. Kg is recalling 5,200 packages of Urispec 11-Way Reagent Test Strips because one of the test pads used to detect leukocytes (white blood cells) was missing from some strips. This defect was discovered after a customer complaint through Henry Schein Inc. Without the leukocyte pad, the test may provide a false negative result even if white blood cells are present in the urine. Consumers who have the affected lot should contact their healthcare provider or the manufacturer for further instructions.

Risk

A missing leukocyte test pad can cause a false negative result, which may lead to a delay in diagnosing urinary tract infections or inflammatory kidney conditions. This delay could result in more serious health complications if an underlying infection or renal issue goes untreated.

What You Should Do

  1. Identify your product by checking the packaging for 'Urispec 11-Way Reagent Test Strips' with Item Number 102-2285.
  2. Verify if your product belongs to the affected batch by looking for LOT 65402 and UDI/DI 00304040001479 on the bottle or box label.
  3. If your strips are from LOT 65402, stop using them for diagnostic testing immediately, as they may provide inaccurate results for leukocytes.
  4. Contact your healthcare provider if you have recently used these test strips and are concerned about the accuracy of your results or if you are experiencing symptoms of a urinary tract infection.
  5. Contact Macherey Nagel Gmbh & Co. Kg or your distributor, Henry Schein Inc., for instructions on how to return the product and obtain a replacement or refund.
  6. For additional questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹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: Urispec 11-Way Reagent Test Strips (5,200 packages)
Model / REF:
102-2285
00304040001479
Lot Numbers:
65402

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94454
Status: Active
Manufacturer: Macherey Nagel Gmbh & Co. Kg
Sold By: Henry Schein Inc.
Manufactured In: Germany
Units Affected: 5,200 packages
Distributed To: Colorado, Florida, Indiana, Nevada, Texas

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

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.