Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-
Summary
The FDA issued a Class I for Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99CO by SD Biosensor, Inc.. Reason: The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buff.
Details
Source
Device Recall
External ID
Z-1594-2023
Action Date
2023-05-31
Status
Ongoing
Category
device
Product Description
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
Lot/Code Info: Lot Numbers: 53K41T5T1 53K41X1T1 53K41X2T1 53K41X3T1 53K4211T1 53K4212T1 53K4213T1 53K4221T1 53K4222T1 53K4223T1 53K4224T1 53K4225T1 53K4231T1 53K4232T1 53K4233T1 53K4261T1 53K4262T1 53K4271T1 53K4272T1 53K4273T1 53K4274T1 53K4291T1 53K4292T1 53K42A1T1 53K42A2T1 53K42A3T1 53K42E1T1 53K42G1T1 53K42G2T1 53K42H1T1 53K42H2T1 53K42L1T1 53K42L2T1 53K4361AC 53K4362AC 53K4392AC 53K38N3T1 53K38N2T1 53K38N1T1 53K38N4T1 53K38N5T1 53K38P1T1 53K38P2T1 53K38P3T1
Quantity Affected: 2,712,767 kits
Reason for Recall
The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-31
Company
Suwon, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 141 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SD Biosensor, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (SD Biosensor, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SD Biosensor, Inc. have FDA actions?
SD Biosensor, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1594-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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