CLASS I Device recall · Reported 16 Feb 2022 · FDA Enforcement Report
Covid-19 Direct Antigen Rapid Test ; E25Bio Covid-19 Dart Kit recalled
E25Bio is recalling E25Bio Covid-19 Direct Antigen Rapid Test ; E25Bio Covid-19 Dart Kit, distributed nationwide in the US. The recall was initiated on 27 Jan 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0564-2022
- FDA event ID
- 89485
- Recalling firm
- E25Bio, Cambridge, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 27 Jan 2022
- FDA classified
- 9 Feb 2022
- Reported
- 16 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Jan 2022 | Recall initiated by company | |
| 9 Feb 2022 | Classified by FDA | +13 days |
| 16 Feb 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Where it was distributed
US Nationwide distribution in the states of MA, FL, and HI.
Questions about this recall
Is Covid-19 Direct Antigen Rapid Test ; E25Bio Covid-19 Dart Kit recalled?
Yes. E25Bio recalled Covid-19 Direct Antigen Rapid Test ; E25Bio Covid-19 Dart Kit on 27 Jan 2022. The recall is Class I and its status is Terminated. Recall number Z-0564-2022.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the states of MA, FL, and HI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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