FDA Medical Device Recalls (openFDA)
WHPM Inc.: First SIGN SARS-CoV-2 Antigen Test
- Recall number
- Z-0892-2022
- Recalling firm
- WHPM Inc.
- Product
- First SIGN SARS-CoV-2 Antigen Test
- Status
- Terminated
- Initiated
- 2022-03-04
- Posted
- not on file
- Terminated
- 2025-02-05
- Reason
- 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.
- 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: dhe@whpm.com Tel: 626.434.8480 For questions or assistance, contact 626.434.8480, or email dhe@whpm.com.
- Quantity
- 535,755 tests
- Distribution
- U.S.: CA, FL, LA, MA and TX O.U.S.: N/A
- Lot, serial or model codes
- Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3003102569
- Firm city
- Irwindale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28