WHAT HAPPENS IF YOU USE NON-FDA-APPROVED VETERINARY TEST KITS?
A Serious Warning for Practicing Veterinarians
By Dr. Geoff Carullo, DVM, FPCCP, DPCVSCA
This is not exaggeration.
This is not fear-mongering.
These are real, documented consequences that can destroy your license, your clinic, and your career.
Many veterinarians do not fail because of lack of skill.
They fail because they cut corners, trusted the wrong supplier, or ignored compliance.
Read this carefully.
1. You Are Immediately in VIOLATION of FDA LAW
The moment you use a non-FDA-approved or unregistered diagnostic test kit, you are:
- Violating RA 3720 and RA 9711
- Using an illegal medical device
- Exposed to FDA inspection, seizure, and sanctions
Clinical opinion does not override the law.
“Working results” do not cancel illegality.
2. You Can Face ADMINISTRATIVE CASES
If a patient dies, is misdiagnosed, or a client complains:
- FDA investigation is triggered
- PRC can be involved
- Your veterinary license may be suspended or revoked
- You gain a permanent professional record
And remember this clearly:
No supplier will defend you once a case is filed.
You stand alone.
3. CRIMINAL LIABILITY IS POSSIBLE
This is where many veterinarians panic — because this is real.
If harm is linked to the use of illegal test kits, you may face:
- Criminal negligence
- Heavy fines
- Possible imprisonment
- Civil damages from clients
Statements like:
“It gives the same result”
have zero value in court.
Only one question matters:
“Was the test kit FDA-approved?”
4. ONE SOCIAL MEDIA POST CAN END YOUR PRACTICE
All it takes is one client post saying:
“Our vet used a test kit without FDA approval.”
What follows:
- Screenshot sharing
- Public outrage
- Online shaming
- Media attention
- Regulatory audit
Screenshots do not disappear.
Reputations do.
5. WHY NON-FDA TEST KITS ARE CLINICALLY DANGEROUS
This is not just legal — this is medical risk.
Non-approved kits often have:
- No validated sensitivity or specificity
- No batch traceability
- No recall system
- No accountability when errors occur
When results are wrong, you are blamed, not the test kit.
6. “IT’S CHEAPER” IS NEVER A DEFENSE
Not to:
- FDA
- PRC
- Courts
- Clients
- Grieving pet owners
The question will always be:
“Doctor, is this FDA-approved?”
If the answer is no, your explanation no longer matters.
7. REMEMBER WHO YOU ARE
You are not a reseller.
You are a licensed medical professional.
Your license is:
- Difficult to earn
- Easy to lose
- Nearly impossible to recover once your name is damaged
One illegal test kit.
One bad decision.
Years of hard work — gone.
FINAL WARNING
If a supplier offers you test kits that are:
- Unregistered
- Without FDA papers
- “Direct import”
- “Same quality, cheaper”
- “Everyone uses it anyway”
Walk away. Immediately.
They will not stand beside you in court.
They will not protect your license.
They will not save your career.
Protect your patients.
Protect your license.
Protect your name.
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