Device recall: CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Class I FDA enforcement event 89315. Recall start date: . Status in the FDA record: Completed.
Reason for recall, in the words of FDA
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Empowered Diagnostics LLC started this device recall on 22 Dec 2021. The firm address in the FDA record is in Pompano Beach, FL. FDA put the recall in Class I. FDA event 89315 has 2 product records. The first FDA enforcement report date is 9 Feb 2022. The record gives the status Completed.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide Distribution
Recalling firm
Empowered Diagnostics LLC, Pompano Beach, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0480-2022 | CovClear COVID-19 Rapid Antigen Test, ATG 900-031 | 284,575 units | Class I | Completed | 9 Feb 2022 |
| Z-0481-2022 | ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 | 2100 units | Class I | Completed | 9 Feb 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class I
- 8%
- Product records in this event
- 2
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-0480-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 89315. https://recallregister.com/fda/i/89315/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide Distribution
- What quantity of product is in FDA event 89315?
- The event has 2 product records. The first record gives this quantity:
284,575 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 8% of the 900 device events that started in 2021 are in Class I.