First SIGN SARS-CoV-2 Antigen Test
Recall
- Recall Number
- Z-0892-2022
- Event Number
- 89676
- Firm
- WHPM Inc.
- FEI Number
- 3003102569
- Product Code
- QKP
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- March 4, 2022
- Terminated
- February 5, 2025
- Address
- 5358 Irwindale Ave, Ste B, Irwindale, CA, 91706-2086
Description
First SIGN SARS-CoV-2 Antigen Test
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.
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].
U.S.: CA, FL, LA, MA and TX O.U.S.: N/A
535,755 tests