Recall Z-0892-2022— WHPM Inc.
Class II · Terminated
Class II FDA medical device recall by WHPM Inc., initiated 2022-03-04, terminated 2025-02-05. FDA's recall record names no specific 510(k) clearance for this event. Product: First SIGN SARS-CoV-2 Antigen Test. Reason: 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..
- Recalling firm
- WHPM Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-03-04
- Terminated
- 2025-02-05
- Firm location
- Irwindale, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.