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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 SIGNsee related information
Date Initiated by FirmMarch 04, 2022
Create DateApril 07, 2022
Recall Status1 Terminated 3 on February 05, 2025
Recall NumberZ-0892-2022
Recall Event ID 89676
Product Classification Coronavirus antigen detection test system. - Product Code QKP
ProductFirst 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;
FEI Number 3003102569
Recalling Firm/
Manufacturer		 WHPM Inc.
5358 Irwindale Ave Ste B
Irwindale CA 91706-2086
For Additional Information ContactSherry Wang
626-443-8480
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
ActionOn 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 Commerce535,755 tests
DistributionU.S.: CA, FL, LA, MA and TX O.U.S.: N/A
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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