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 qu
Summary
The FDA issued a Class II for T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only Th by BioCheck, Inc.. Reason: Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls..
Details
Source
Device Recall
External ID
Z-0214-2022
Action Date
2021-11-17
Status
Terminated
Category
device
Product Description
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.
Lot/Code Info: Lot # RN-60831 or RN-60923
Quantity Affected: 314 kits
Reason for Recall
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
Distribution
US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-14
Company
South San Francisco, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 102 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioCheck, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioCheck, Inc. have FDA actions?
This is the only FDA action we have on record for BioCheck, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0214-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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