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U.S. Department of Health and Human Services

Class 1 Device Recall E25Bio COVID19 DART Kit

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  Class 1 Device Recall E25Bio COVID19 DART Kit see related information
Date Initiated by Firm January 27, 2022
Date Posted February 09, 2022
Recall Status1 Terminated 3 on September 19, 2022
Recall Number Z-0564-2022
Recall Event ID 89485
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Code Information 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
Recalling Firm/
Manufacturer		 E25Bio, Inc.
501 Massachusetts Ave
The Engine
Cambridge MA 02139-4018
Manufacturer 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.
FDA Determined
Cause 2		 No Marketing Application
Action On January 27, 2022, the firm began sending customers Urgent Medical Device Recall letters. Customers were instructed to do the following: ¿ Immediately examine your inventory for the affected product and quarantine any that are identified ¿ Do not use the COVID-19 Direct Antigen Rapid Test to diagnose or screen any individuals for COVID-19 ¿ Destroy the tests by placing them in the trash; alternatively, contact info@e25bio.com for assistance in removing these products from your inventory ¿ Complete and return the response form to the firm as soon as possible, indicating the number of destroyed tests and the date in which the destruction of the tests took place; you may email the completed form to info@e25bio.com or recall@e25bio.com. Please complete the form even if you do not have affected product on hand. ¿ If any Tests were distributed to third parties for their own use or for further distribution, please notify the firm of that information and include their identities as part of your Return Response. The enclosed form includes a section for that information to be provided. If you have any questions or concerns regarding this notice, please contact us at info@e25bio.com.
Quantity in Commerce 73,300 units
Distribution US Nationwide distribution in the states of MA, FL, and HI.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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