Description
Warranty
Limited Warranty, Waivers and Limitations
Limited Product Warranty
BIOBASE SARS-CoV-2 Antigen Rapid Test Kits are warranted to be free from material defects in manufacturing, packaging, and workmanship when stored, transported, handled, and used strictly in accordance with the current Instructions for Use, product labeling, and applicable regulatory requirements.
Unless otherwise stated in the applicable quotation, purchase agreement, or manufacturer documentation, the warranty period is limited to 12 months from the documented date of delivery and may not extend beyond the printed expiration date of the affected product.
This limited warranty applies only to unopened, unused products that remain in their original packaging and have been maintained within the manufacturer-specified storage conditions.
Exclusive Warranty Remedy
For a verified warranty claim, the seller’s sole obligation and the purchaser’s exclusive remedy will be, at the seller’s discretion:
Replacement of the verified defective units;
Issuance of a credit for the affected units; or
Refund of the original purchase price paid for the affected units.
The seller is not responsible for replacement labor, testing expenses, disposal costs, freight, customs charges, business interruption, lost revenue, or any other incidental or consequential expense unless expressly agreed to in writing.
Warranty Exclusions
This warranty does not cover claims resulting from:
Use after the printed expiration date;
Improper storage, refrigeration, freezing, overheating, moisture exposure, or temperature excursion;
Improper transportation, handling, repacking, relabeling, or distribution;
Opening the sealed pouch before the product is ready for immediate use;
Failure to follow the Instructions for Use;
Incorrect sample collection, extraction, application, timing, or result interpretation;
Use with unauthorized accessories, reagents, buffers, or collection devices;
Product alteration, tampering, contamination, misuse, negligence, or abuse;
Damage caused by fire, flood, accident, natural disaster, or other events beyond the seller’s reasonable control;
Use outside the product’s intended purpose or outside an authorized jurisdiction;
Normal variation in biological specimens or antigen concentration;
False-positive, false-negative, inconclusive, or invalid results that are not attributable to a verified manufacturing defect; or
Products purchased from an unauthorized reseller or without valid proof of purchase and lot traceability.
Diagnostic and Clinical Waiver
This product is an in vitro diagnostic screening device and is not intended to serve as the sole basis for diagnosis, treatment, isolation, discharge, or other clinical decisions.
Test results must be interpreted together with:
Patient symptoms;
Exposure history;
Epidemiological information;
Current public-health guidance; and
Confirmatory laboratory testing when clinically indicated.
A negative result does not completely exclude SARS-CoV-2 infection. A positive result may require confirmation under applicable local protocols. The seller and manufacturer do not guarantee that the product will detect every infection or produce a correct result in every individual case.
Performance Disclaimer
Any sensitivity, specificity, accuracy, or other performance values displayed in product materials are based on manufacturer-supplied data and the study conditions identified in the applicable technical documentation.
Actual performance may vary depending on specimen quality, disease stage, antigen concentration, circulating variants, operator technique, storage conditions, timing, patient characteristics, and other clinical or environmental factors.
No performance statement constitutes a guarantee of an individual diagnostic outcome.
Regulatory and Distribution Limitation
The purchaser is responsible for confirming that the product is lawfully registered, imported, distributed, marketed, and used in the destination jurisdiction.
Manufacturer literature states that this product is not available for sale or distribution in the United States. The product must not be offered, imported, distributed, or used in the United States unless the specific product has received all required authorization, clearance, approval, or exemption from the appropriate regulatory authorities.
No FDA authorization, clearance, or approval is represented by this listing.
Limitation of Liability
To the fullest extent permitted by applicable law, the total cumulative liability of the seller, distributor, and manufacturer arising from the sale or use of the product will not exceed the amount actually paid for the specific affected units.
Neither the seller, distributor, nor manufacturer will be liable for indirect, incidental, special, exemplary, punitive, or consequential damages, including loss of revenue, loss of business, loss of data, loss of opportunity, patient-management costs, testing expenses, or reputational harm.
Nothing in this section excludes or limits liability that cannot legally be excluded or limited under applicable law.
Disclaimer of Other Warranties
Except for the limited written warranty stated above, the product is provided without any additional express or implied warranty.
To the fullest extent permitted by law, all implied warranties—including merchantability, fitness for a particular purpose, non-infringement, and suitability for a specific clinical, institutional, governmental, or commercial application—are disclaimed.
Certain jurisdictions do not permit limitations on implied warranties or consequential damages. In those jurisdictions, the limitations will apply only to the maximum extent legally permitted.
Warranty Claim Requirements
A warranty claim must be submitted promptly after discovery of the alleged defect and must include:
Purchaser name and order number;
Product name and SKU;
Lot or batch number;
Expiration date;
Quantity affected;
Photographs of the product and packaging;
Description of the alleged defect;
Storage and transportation records, when requested;
Temperature-excursion information, when applicable; and
Proof of purchase from an authorized seller.
Affected products must not be destroyed, returned, altered, or discarded until written instructions are provided. Return authorization may be required before any product is shipped.
Acceptance of Terms
Purchase, receipt, resale, distribution, opening, or use of the product constitutes acknowledgment of these warranty terms, limitations, regulatory conditions, and product-use disclaimers, except where otherwise prohibited by applicable law.