T4 EIA Kit (BioCheck) – Shelf-Life Control Failure (2021)
Test kit not meeting shelf-life standards can impact quality control.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
BioCheck, Inc.
Lot Codes / Batch Numbers
Lot # RN-60831 or RN-60923
Products Sold
Lot # RN-60831 or RN-60923
BioCheck, Inc. is recalling T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intende due to Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
Recommended Action
Per FDA guidance
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: jsaito@biocheckinc.com 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: jsaito@biocheckinc.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, MI, NJ, OH
Page updated: Jan 10, 2026