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U.S. Department of Health and Human Services

Class 2 Device Recall Total Thyroxine (T4) Enzyme Immunoassay Test Kit

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  Class 2 Device Recall Total Thyroxine (T4) Enzyme Immunoassay Test Kit see related information
Date Initiated by Firm October 14, 2021
Date Posted November 10, 2021
Recall Status1 Open3, Classified
Recall Number Z-0214-2022
Recall Event ID 88869
510(K)Number K991432  
Product Classification Enzyme immunoassay, non-radiolabeled, total thyroxine - Product Code KLI
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.
Code Information Lot # RN-60831 or RN-60923
Recalling Firm/
Manufacturer		 BioCheck, Inc.
425 Eccles Ave
South San Francisco CA 94080-1902
For Additional Information Contact Johanna Saito
650-573-1968
Manufacturer Reason
for Recall		 Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
FDA Determined
Cause 2		 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: 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.
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KLI and Original Applicant = BIOCHECK, INC.
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