First SIGN SARS-CoV-2 Antigen Test recall
First SIGN SARS-CoV-2 Antigen Test
Why was First SIGN SARS-CoV-2 Antigen Test 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041;
- Product
- First SIGN SARS-CoV-2 Antigen Test
- Recalling firm
- WHPM Inc.
- Quantity
- 535,755 tests
- Distribution
- U.S.: CA, FL, LA, MA and TX O.U.S.: N/A
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)