LumiraDx SARS-CoV-2, Manual

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Document Name: SARS-CoV-2 Antigen (Ag) Quality Controls Pack Insert
Document Number: S-COM-DOUT-00132 Revision: 2
This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for
the most recent version unless formally issued and stamped by QA. Created with S-QMS-TEM-00002
Indicates that potential biological risks are associated with the Quality
Control material.
Refer to instructions for use
Authorized representative in the European Community
Indicates a negative control
Indicates a positive control
LumiraDx customer services:
For product inquiries please contact LumiraDx Customer Services by email:
customerservices.US@lumiradx.com or telephone 1-888-586-4721
Any adverse results experienced with the use of this product, and/or quality problems should also be
reported to LumiraDx Customer Services by email: customerservices.US@lumiradx.com or at
lumiradx.com.
For return policy
If there is a problem with the LumiraDx SARS-CoV-2 Ag Quality Controls Pack you may be asked to
return them. Before returning tests please obtain a return authorization number from LumiraDx
Customer Services. This return authorization number must be on the shipping carton for return. For
ordinary returns following purchase, please contact LumiraDx Customer Services for terms and
conditions.
Limited warranty
LumiraDx SARS-CoV-2 Ag Quality Controls Pack – As per shelf life.
For the applicable warranty period, LumiraDx warrants that each product shall be (i) of good quality and
free of material defects, (ii) function in accordance with the material specifications referenced in the
pack insert, and (iii) approved by the proper governmental agencies required for the sale of products
for their intended use (the “limited warranty”). If the product fails to meet the requirements of the limited
warranty, then as the customer’s sole remedy, LumiraDx shall either repair or replace, at LumiraDx’s
discretion, the LumiraDx SARS-CoV-2 Ag Quality Controls Pack. Except for the limited warranty stated
in this section, LumiraDx disclaims any and all warranties, express or implied, including but not limited
to, any warranty of merchantability, fitness for a particular purpose and non-infringement regarding the
product. LumiraDx’s maximum liability with any customer claim shall not exceed the net product price
paid by the customer. Neither party shall be liable to the other party for special, incidental or