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Amazon Medical Device Recall

Medical Device Recall if you purchased from Amazon

Written by Idha

Voluntary Recall – How to Safely Dispose of Your Kit

GetTested is conducting a voluntary recall of certain test kits that were distributed in the United States. This recall is purely precautionary and does not involve any reports of product failures or health risks.

The affected kits were originally manufactured for European markets and were not authorized for distribution in the U.S. under FDA regulations. To ensure full compliance, customers with unused kits are asked to dispose of them safely following the instructions below.

⚠️ Do not fill out the form if you have already used your kit or submitted your sample.


Used kits do not need to be returned or reported for.


Step 1: Complete the Dispose-of-Kit Form

Please complete the following form to confirm safe disposal of your unused kit(s):
​Dispose-of-Kit Form

This form is required to document the disposal process and ensure regulatory traceability. You are fully responsible for providing complete and accurate information. Incorrect or missing details may prevent your request from being processed.


Step 2: Information Required in the Form

You will need to provide:

  1. Order number – Found in your order confirmation email. If you have multiple unused kits, include all order numbers.

  2. Email address – The same one used when placing your order.

  3. Proof of disposal –

    • Upload two clear photos per kit after rendering it unusable.

    • For example: tear the foil pouch, cut swabs or strips, or remove identifying labels.

    • Do not open any vials or tubes containing liquid or preservatives. Leave them sealed and place the intact tube inside a bag before disposal.

  4. Date and location of disposal – Specify the date and city/state where the kit was discarded.


Step 3: Disposal Instructions

  • Render the kit unusable and unsellable (e.g., open or damage packaging so it cannot be reused).

  • Dispose of the components via ordinary household waste according to local regulations.

  • If any liquid containers are damaged or leaking, seal them in a secondary bag and avoid contact with skin or eyes.

Once completed, confirm disposal in the form and submit your photos.


Step 4: Confirmation

Before submitting, you will be asked to confirm that:

  • You have rendered the kit unusable and safely discarded it.

  • You have provided accurate and complete information.

  • You understand that if corrections are needed, you must update your responses.

Select “Yes, I confirm” to complete the process.


Additional Information

If your kit has already been used, you do not need to dispose of or report it.

If you have already used your kit, sent your sample to the lab and/or already received results, you do not need to fill out the Dispose-of-Kit Form.


This form only applies to unused kits.

If you have questions or need support, contact our recall support team via:

Our team will guide you through the process and confirm once your submission has been recorded.


Product and Distribution Information Table

If your test is not included in the recall list, or if you have already used it, you do not need to fill out the Dispose-of-Kit Form.

Only unused kits from the affected product list need to be reported and safely discarded. All other products can be ignored, and no further action is required.

If you’re unsure whether your test is affected, you can check the Product and Distribution Information Table below or contact us at hello@gettested.us — our team will be happy to confirm it for you.

Product Name

SKU

2 in 1 Trichomonas / Gardnerella Test

B-TOG

3 in 1 STI Test

JD-3STI

8 in 1 STI Test Kit

JD-8STI

CRP (C-Reactive Protein) Test

C-CRP

D-Dimer Test

A-CDM

Epstein-Barr Virus (EBV VCA & EBNA IgG) Test

A-EBV

Iron Deficiency Test

A-FER

Iron Deficiency Test (ferritin)

1FE

Kidney Test

D-KID

Liver Test

D-LIV

Menopause (FSH) 2 Tests

A-FSH

Ovulation Test (5 tests)

A-LH

Thyroid TSH Test

A-TSH

Vitamin D-Test

A-VID

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