LumiraDx Platform Returns

Guidance on Returns

For inquiries regarding your LumiraDx Platform, please contact LumiraDx Technical Services at 1-888-586-4721 (option 1) or email Technicalservices.us@Lumiradx.com.

When a LumiraDx Platform return is necessary, a LumiraDx Representative will provide a case number, a shipping return label, and a Return Authorization Form.

Follow these steps to ensure the LumiraDx Platform is processed correctly before returning:

1. Personal Identifiable Data

   Technical Services will discuss and agree on the handling of Personal Identifiable Data, which can be one of the following:

   • Data Deletion: LumiraDx requests customers to remove any personal identifiable information before returning the LumiraDx Instrument. LumiraDx will not be liable for any remaining data and will remove or delete all remaining data upon return of the LumiraDx Instrument.
   • Data Retention: For quality control and investigation purposes, LumiraDx requests that customers do not remove any personal identifiable information before returning the LumiraDx Instrument. Upon completion of the investigation, the data will be securely deleted and will not be available to the customer.

2. Disinfection

   LumiraDx requests that customers clean and disinfect the items being returned according to the instructions provided in the Platform User Manual, section 5.

3. Packaging

   Please follow the instructions below when returning the LumiraDx Platform:

   • Unused strips and unused controls: Should remain in their primary packaging and be returned in suitable packaging.
   • Used Test strips: Should only be returned in appropriate sealed packaging for the shipment of Hazardous Goods and must be appropriately labelled and identified.

Instrument and Hardware Packaging

Instruments and other hardware, including the power supply unit, should be returned in their original packaging. If original packaging is unavailable, use the replacement Instrument packaging. If neither is available, follow the instructions below for packaging the LumiraDx Instrument.

IMPORTANT: Improper packaging during transportation and shipping can lead to further damage, hindering the investigation process.

1. Ensure the instrument is switched off. ?
2. Place the instrument in the foam tray within the packaging. The power cord should be placed in the enclosed box adjacent to the instrument.
3. Close the packaging.
4. Slide the foam end caps on and place in the larger shipper box. Lay the signed Customer Returns Declaration form on top.
5. Secure the shipping box with packing tape and affix the provided shipping returns label.

If using your own packaging:

• Instruments should be encased in bubble wrap and/or similar available packaging material before placing in the shipping box.
• Utilize properly sized shipping boxes to limit movement of contents and help mitigate damage during transit. [box-with-bubble-wrap] [open-shipping-box] [sealed-shipping-box]

Package Pickup

Arrange for package pickup with your respective courier or LumiraDx Representative for the returns items as soon as possible.

Manufacturer Information

Manufactured by: LumiraDx UK Ltd, Dumyat Business Park, Alloa, FK10 2PB, UK. Registration Number: 09206123.

The LumiraDx SARS-CoV-2 Ag Test and the LumiraDx SARS-CoV-2 Ab Test have not been cleared or approved by FDA, but have been authorized for emergency use by FDA under an EUA for use by authorized laboratories. The LumiraDx SARS-CoV-2 Ag Test has been authorized only for the detection of proteins from SARS-CoV-2. The LumiraDx SARS-CoV-2 Ab Test has been authorized only for detecting the presence of total antibodies to SARS-CoV-2. They have not been authorized for use to detect any other viruses or pathogens. The Tests are authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic Tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.