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

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

Healgen Scientific Llc: Urinary Reagent Strips Recalled for False Negative Protein Results

Agency Publication Date: September 27, 2024
Share:
Sign in to monitor this recall

Summary

Healgen Scientific is recalling approximately 1,636,994 urinary reagent test strips because they may show reduced sensitivity or false negative results for protein in urine. This defect is caused by uneven color fading on the test pad, which can make it difficult to accurately read the results. The recall affects several models including Urinox-P30, URS-11T, Urinox10-30, URS-10T, Urinox10-20, Urinox-10-60, and URS-4T. These strips are used to screen for various health markers, and inaccurate readings could lead to serious medical delays.

Risk

A false negative result means the test may fail to detect elevated protein levels in the urine even when they are present. This can cause a delay in identifying and treating kidney disease or other serious medical conditions associated with high protein levels.

What You Should Do

  1. Check your product packaging for the following Product Item Codes: Urinox-P30, URS-11T, Urinox10-30, URS-10T, Urinox10-20, Urinox-10-60, or URS-4T.
  2. Verify if your product matches one of the affected Lot Numbers: N2310003, N2310012, N2305013, N2308006, N2209013, N2302034, N2303002, N2311002, N2306012, N2311004, N2305015, N2305025, N2308011, N2309011, N2302027, N2302032, N2311007, N2306001, N2306013, N2308004, N2309002, N2211004, N2305014, N2305024, N2308010, N2309010, N2302031, N2305026, N2306006, N2308012, N2302028, N2302033, or N2306014.
  3. Identify the product using the UDI-DI codes: 196852593453, 00816490024347, 099654011043, 00816490024323, 707486987534, 707486987053, or 00816490024330.
  4. Contact your healthcare provider or Healgen Scientific Llc at 1-888-463-6332 for further instructions and information regarding a potential refund or replacement.
  5. For additional questions, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

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

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

Affected Products

Product: Urinox-P30 Reagent Strips for Urinalysis
Model / REF:
Urinox-P30
UPC Codes:
196852593453
Lot Numbers:
N2310003
N2310012
N2305013
N2308006
N2209013
N2302034
N2303002
Product: URS-11T Reagent Strips for Urinalysis
Model / REF:
URS-11T
UPC Codes:
00816490024347
Lot Numbers:
N2311002
N2306012
Product: Urinox10-30 Reagent Strips for Urinalysis
Model / REF:
Urinox10-30
UPC Codes:
099654011043
Lot Numbers:
N2311004
N2305015
N2305025
N2308011
N2309011
N2302027
N2302032
Product: URS-10T Reagent Strips for Urinalysis
Model / REF:
URS-10T
UPC Codes:
00816490024323
Lot Numbers:
N2311007
N2306001
N2306013
N2308004
N2309002
N2211004
Product: Urinox10-20 Reagent Strips for Urinalysis
Model / REF:
Urinox10-20
UPC Codes:
707486987534
Lot Numbers:
N2305014
N2305024
N2308010
N2309010
N2302031
Product: Urinox-10-60 Reagent Strips for Urinalysis
Model / REF:
Urinox-10-60
UPC Codes:
707486987053
Lot Numbers:
N2305026
N2306006
N2308012
N2302028
N2302033
Product: URS-4T Reagent Strips for Urinalysis
Model / REF:
URS-4T
UPC Codes:
00816490024330
Lot Numbers:
N2306014

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95248
Status: Active
Manufacturer: Healgen Scientific Llc
Manufactured In: United States
Units Affected: 1,636,994 Tests
Distributed To: California, Georgia, 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.