Z-0892-2022Class II

First SIGN SARS-CoV-2 Antigen Test

Name: Z-0892-2022 First SIGN SARS-CoV-2 Antigen Test
Creator: WHPM Inc.
Published: 2022-03-04
License: https://open.fda.gov/license/

WHPM Inc. / initiated 2022-03-04 / Terminated

FDA source

WHPM Inc. began a recall of First SIGN SARS-CoV-2 Antigen Test on 2022-03-04. FDA classified it as Class II and gives the reason as "Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold domestically by a pharmacy in California. These Antigen Tests have not received FDA Emergency Use Authorization...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0892-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-04
Posted: 2022-04-07
Terminated: 2025-02-05
Recalling firm: WHPM Inc.
Product: First SIGN SARS-CoV-2 Antigen Test
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold domestically by a pharmacy in California. These Antigen Tests have not received FDA Emergency Use Authorization, nor have these tests been cleared or approved by FDA for commercial distribution in the U.S.
FDA root cause: No Marketing Application
Action: On 03/04/2022, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx to customers informing them that, their SARS-CoV-2 Antigen Tests does not have FDA approvals, clearances, or emergency use authorization and cannot be distributed in the U.S. Use of the affected product could result in false-negative and/or false-positive results and could lead to a delay in the correct diagnosis and the initiation of an appropriate treatment. Customer are instructed to: -Stop/Cease using/distributing the Antigen device in their possession; -Count the tests in their possession and write the number on the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form and return the form -With the pre-addressed FedEx label return test kits. Return Response Forms and affected products to: Attn: David He WHPM Inc. 5358 Irwindale Avenue, Irwindale, CA 91706 Email: [email protected] Tel: 626.434.8480 For questions or assistance, contact 626.434.8480, or email [email protected].
Quantity in commerce: 535,755 tests
Distribution: U.S.: CA, FL, LA, MA and TX O.U.S.: N/A
Product codes and lots: Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0892-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0892-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-07

Product code QKP

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)