Class II U.S. Food and Drug Administration

Get Tested International Ab Continuous Glucose Monitor recall: Distribution without premarket approval/clearance

Recall published 11 months ago

Distribution without premarket approval/clearance.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0770-2026
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
4 units
Distribution
Nationwide
Made in
Sweden
Lot / code info
EAN: 7340221708952; SKU: CGM-15D; UDI-DI: None; Lot/Serial Number: All Lots;
UPC codes
7340221708952

Products covered by this recall

Continuous Glucose Monitor (CGM)

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.

  • 7340221708952

Model or item number

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

  • CGM-15D

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 Device

Get Tested International Ab — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

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 7340221708952; model number CGM-15D. 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?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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