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U.S. Department of Health and Human Services

Class 2 Device Recall First SIGN

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  Class 2 Device Recall First SIGN see related information
Date Initiated by Firm March 04, 2022
Create Date April 07, 2022
Recall Status1 Open3, Classified
Recall Number Z-0892-2022
Recall Event ID 89676
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product First SIGN SARS-CoV-2 Antigen Test
Code Information Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041;
Recalling Firm/
5358 Irwindale Ave Ste B
Irwindale CA 91706-2086
For Additional Information Contact Sherry Wang
Manufacturer 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 Determined
Cause 2
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 in Commerce 535,755 tests
Distribution U.S.: CA, FL, LA, MA and TX O.U.S.: N/A
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.