T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.

Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.

On October 14, 2021 BioCheck issued a "Medical Device Recall Notification" to affected customers. In addition to informing consignees about the recall, BioCheck asked consignees to take the following actions: 1) Please immediately discontinue use or distribution of the affected lots. 2) If you have further distributed the affected product lots, please identify those customers and notify them at once of this product recall. 3) If you have relabeled or rebranded the affected product lots, please follow your internal recall process and notify appropriate regulatory bodies, if required. 4) Disposal of all affected lots should be in accordance with applicable national, state, and local laws and regulations. 5) Complete and return the enclosed Return Response Form by October 29, 2021 to BioCheck, Inc,, 425 Eccles Avenue, South San Francisco, CA 94080 or email to: [email protected] as is required to meet subsequent FDA Status Reporting requirements. CUSTOMER CREDIT 8. Upon receipt of completed Return Response Form, customer's account will be credited for the identified products that are disposed of. If you have any questions, contact Director QA/RA at (650) 573-1968 or email: [email protected].