Reported Feb 16, 2022 · Terminated
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
E25Bio, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: E25Bio, Inc. · 501 Massachusetts Ave · Cambridge, MA · 02139-4018
Is this the product you have?
E25Bio COVID-19 Direct Antigen Rapid TestE25Bio COVID-19 DART Kit
- Lot codes and dates
- Lot numbers are unavailable. The following
- Purchase Orders and Dates are affectedPurchase Order/Invoice Number Date
100610/13/2020100711/13/2020100811/25/2020100912/18/2020101001/07/2021101101/07/2021101201/07/2021101101/07/202110151/29/2021101602/03/202110192/26/202110172/23/202110213/05/202110233/19/2021102704/05/2021103911/03/2021104011/03/202110284/16/202110295/10/2021103209/03/2021107311/27/2020
- Amount recalled
- 73,300 units
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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