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Class 2 Device Recall First SIGN |
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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
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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/ Manufacturer |
WHPM Inc. 5358 Irwindale Ave Ste B Irwindale CA 91706-2086
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For Additional Information Contact |
Sherry Wang 626-443-8480
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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.
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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
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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.
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