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BioCheck, Inc. Recall 88869

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.

BioCheck, Inc. Recall 88869 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0214-2022
Event ID88869
Event DescriptionT4 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 TypeDevices
DistributionUS Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria
Quantity314 kits
Recall ReasonImmunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
Device Classification20211117
Device Code InfoLot # RN-60831 or RN-60923
Center Classification Date20211110
Recall Initiation Date20211014
Recalling FirmBioCheck, Inc.
Initial Notification Letter
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