Unauthorized SARS-CoV-2 Antigen Tests recalled for lack of FDA clearance
WHPM Inc. is recalling approximately 535,755 First SIGN SARS-CoV-2 Antigen Tests distributed in California, Florida, Louisiana, Massachusetts, and Texas. The tests were sold without FDA Emergency Use Authorization or clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall involving unvalidated diagnostic tests distributed without FDA Emergency Use Authorization or clearance. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High score (3).
Plain-English summary
WHPM Inc. is recalling First SIGN SARS-CoV-2 Antigen Tests (approximately 535,755 units). The affected tests were distributed to customers in California, Florida, Louisiana, Massachusetts, and Texas.
These tests were sold without FDA Emergency Use Authorization and have not been cleared or approved by the FDA for commercial distribution in the United States. The recall was initiated after the FDA received a customer complaint indicating that a pharmacy in California had sold these unauthorized tests.
Because these tests have not undergone FDA review and authorization, their accuracy and reliability have not been validated by the agency. Consumers who have used these tests should be aware that the results may not be reliable.
The recalled product
- Product
- First SIGN SARS-CoV-2 Antigen Test
- Manufacturer
- WHPM Inc.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 535,755
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078
- F1227210039
- F0809210004
- F0906210010
- P0211214070
- F0914210014
- F1013210020
- F1214210034
- F0121220041
Distribution
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