Z-0481-2022Class I

ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60

Name: Z-0481-2022 ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Creator: Empowered Diagnostics LLC
Published: 2021-12-22
License: https://open.fda.gov/license/

Empowered Diagnostics LLC / initiated 2021-12-22 / Completed

FDA source

Empowered Diagnostics LLC began a recall of ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 on 2021-12-22. FDA classified it as Class I and gives the reason as "COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0481-2022
Classification: Class I
Status: Completed
Initiated: 2021-12-22
Posted: 2022-01-29
Recalling firm: Empowered Diagnostics LLC
Product: ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
FDA root cause: No Marketing Application
Action: The firm notified their direct consignees by letter delivered by email on December 22, 2021. The letter explained the hazard and requested the discontinuation of use and distribution. Those who has further distributed the products, were requested to conduct a sub-recall.
Quantity in commerce: 2100 units
Distribution: US Nationwide Distribution
Product codes and lots: all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0481-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0480-2022	Class I	Completed	Voluntary: Firm initiated	2022-02-09	2022-01-28
Z-0481-2022	Class I	Completed	Voluntary: Firm initiated	2022-02-09	2022-01-28

Product code QKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)