Z-0214-2022Class II

T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is...

Name: Z-0214-2022 T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is...
Creator: BioCheck, Inc.
Published: 2021-10-14
License: https://open.fda.gov/license/

BioCheck Inc / initiated 2021-10-14 / Terminated

FDA source

BioCheck, Inc. began a recall of 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... on 2021-10-14. FDA classified it as Class II and gives the reason as "Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0214-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-14
Posted: 2021-11-10
Terminated: 2025-02-14
Recalling firm: BioCheck Inc
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.
Product code: KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Reason for recall: Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
FDA root cause: Component change control
Action: 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].
Quantity in commerce: 314 kits
Distribution: US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria
Product codes and lots: Lot # RN-60831 or RN-60923

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0214-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0214-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-17	2021-11-10

Product code KLI

K991432Class IIBiocheck Total T4 Enzyme Immunoassay Test Kit, Model Bc-1007Biocheck, Inc. / cleared 1999-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)