Dexcom G7 Sensor Recall

RC-2026-RN-00361-1

What is the problem?

AMSL Diabetes, A Dexcom company, is recalling specific lots of Dexcom G7 sensors. The two lots were intended for destruction due to failure during testing and incomplete sterilisation. During destruction, these devices were stolen and sold to third parties via unauthorised supply channels.

Product Name	Product Code (REF)	ARTG	Lot Numbers
Dexcom G7 sensors	STP-AT-012	472165	1725204004 1725069002

To date there have been no recorded sensor starts for lot 1725204004 outside the United States, however as the supply channels of these lots cannot be established, a risk of these devices reaching Australia cannot be excluded.

This problem only affects the lot numbers listed above; no other lots are impacted.

Is my G7 Sensor Affected?

If available, check the lot number listed on your G7 sensor outer box (see below images Figure 1 and Figure 2). If the lot number on your G7 box is listed in the table above, the device is affected.
If you cannot locate your lot number, please contact Dexcom Technical Support on 1300 851 056.
Dexcom is developing a sensor serial number look-up tool. This webpage will be updated when it is available.

Figure 1, Figure 2

What are the risks?

Risks associated with use of the affected sensors include:

Skin infections
Inaccurate or loss of readings
Missed detection of hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose), which could lead to serious health consequences.

What should I do?

Immediately discontinue use and dispose of affected products.
Replace the affected sensor with an unaffected sensor or use a blood glucose meter for glucose monitoring.
Contact Dexcom Technical Support to request a replacement.
If you have symptoms of infection or inflammation, redness, swelling, or pain, at the insertion site, contact a healthcare provider.

Further information

Please contact Dexcom Technical Support on 1300 851 056 for further information.