First SIGN SARS-CoV-2 Antigen Test
Reported: April 13, 2022 Initiated: March 4, 2022 #Z-0892-2022
Product Description
First SIGN SARS-CoV-2 Antigen Test
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.
Details
- Recalling Firm
- WHPM Inc.
- Units Affected
- 535,755 tests
- Distribution
- U.S.: CA, FL, LA, MA and TX O.U.S.: N/A
- Location
- Irwindale, CA
Frequently Asked Questions
What product was recalled? ▼
First SIGN SARS-CoV-2 Antigen Test. Recalled by WHPM Inc.. Units affected: 535,755 tests.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0892-2022.
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