Summary
The FDA issued a Class I for E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit by E25Bio, Inc.. Reason: The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient direction.
Details
Source
Device Recall
External ID
Z-0564-2022
Action Date
2022-02-16
Status
Terminated
Category
device
Product Description
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Lot/Code Info: Lot numbers are unavailable. The following Purchase Orders and Dates are affected: Purchase Order/Invoice Number Date 1006 10/13/2020 1007 11/13/2020 1008 11/25/2020 1009 12/18/2020 1010 01/07/2021 1011 01/07/2021 1012 01/07/2021 1011 01/07/2021 1015 1/29/2021 1016 02/03/2021 1019 2/26/2021 1017 2/23/2021 1021 3/05/2021 1023 3/19/2021 1027 04/05/2021 1039 11/03/2021 1040 11/03/2021 1028 4/16/2021 1029 5/10/2021 1032 09/03/2021 1073 11/27/2020
Quantity Affected: 73,300 units
Reason for Recall
The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.
Distribution
US Nationwide distribution in the states of MA, FL, and HI.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-27
Company
Cambridge, MA
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 154 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (E25Bio, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does E25Bio, Inc. have FDA actions?
This is the only FDA action we have on record for E25Bio, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0564-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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