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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

Quidel Corporation: InflammaDry MMP-9 Tests Recalled for Misaligned Result Windows

Agency Publication Date: April 24, 2024
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Summary

Quidel Corporation is recalling approximately 135,440 units of the InflammaDry MMP-9 Test because the test result windows are misaligned. This defect can cause the positive test line to be hidden under the plastic cassette, making it impossible for a user to see a positive result. This manufacturing error affects two specific product versions (REF: PRS-ID-20-U and PRS-ID-20) distributed across 44 U.S. states and several international locations. Consumers should contact their healthcare provider or the manufacturer regarding affected units.

Risk

A misaligned test line can be hidden behind the device's plastic casing, causing a user to receive a false negative result when they are actually positive for MMP-9. This could lead to a delay in diagnosis or improper treatment for inflammatory eye conditions.

What You Should Do

  1. Check your InflammaDry MMP-9 Test kits for the following identifying information: REF PRS-ID-20-U (Lot # 162621, 162695, 162498, 162718, 162749, or 163025) and REF PRS-ID-20 (Lot # 162620 or 162748).
  2. Verify the UDI numbers on the packaging: 30014613336754 for PRS-ID-20-U or 30014613336747 for PRS-ID-20.
  3. If you have an affected test kit, contact your healthcare provider or Quidel Corporation at 1-888-463-6332 for guidance on how to handle the product.
  4. Healthcare professionals should stop using tests from these specific lots and contact the manufacturer for further instructions regarding replacements or refunds.
  5. Contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification

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

Affected Products

Product: QUIDEL InflammaDry MMP-9 Test, 20 Tests (REF: PRS-ID-20-U)
Model / REF:
PRS-ID-20-U
Lot Numbers:
162621
162695
162498
162718
162749
163025
Product: QUIDEL InflammaDry MMP-9 Test, 20 Tests (REF: PRS-ID-20)
Model / REF:
PRS-ID-20
Lot Numbers:
162620
162748

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94219
Status: Active
Manufacturer: Quidel Corporation
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 2 products (104,300 units; 31,140 units)
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia

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.