Class II U.S. Food and Drug Administration

Get Tested International Ab Heavy Metals Test recall: Distribution without premarket approval/clearance

Recall published 11 months ago

Distribution without premarket approval/clearance.

The hazard: Lead or heavy metal content

The recall is about heavy metal content exceeding what U.S. law allows in a product children handle.

What the notice says: Distribution without premarket approval/clearance.

Why it matters: The product exceeds the federal limit on lead or another heavy metal. Lead harms the developing brain, and the damage builds quietly from small repeated exposures rather than arriving as a single dramatic poisoning.

Symptoms and when to call a doctor

The CDC states there is no known safe level of lead in a child’s blood, and that most children with elevated levels show no symptoms at all. That is why a blood lead test, not a symptom check, is the way to find out. Ask your paediatrician about testing if a child has handled, mouthed or worn the product regularly. Where symptoms do appear they are non-specific — irritability, poor appetite, stomach pain, tiredness, constipation or a drop in attention and learning.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0809-2026
Published
December 10, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Get Tested International Ab
Product type
Medical devices
Units affected
50 units
Distribution
Nationwide
Made in
Sweden
Lot / code info
EAN: 616612785749; SKU: 1SM; UDI-DI: None; Lot/Serial Number: All Lots;
UPC codes
616612785749

Products covered by this recall

Heavy Metals Test

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 616612785749

Model or item number

On the rating label, the box or the instruction sheet.

  • 1SM

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Lead

Get Tested International Ab — The recall is about heavy metal content exceeding what U.S. law allows in a product children handle.

  1. Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.
  2. Follow the remedy on this page — lead recalls almost always carry a full refund.
  3. Wash the hands of anyone who has been handling it, and wipe down the surfaces it has been sitting on.
  4. Ask your paediatrician whether a blood lead test is warranted, especially for a child under six or anyone pregnant.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.

Company contact: GET TESTED INTERNATIONAL AB — 59334 Vastervik, Vastervik

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Get Tested International Ab medical devices recalled?

Distribution without premarket approval/clearance. Distribution without premarket approval/clearance.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 616612785749; model number 1SM. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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