Summary
The FDA issued a Class II for First SIGN SARS-CoV-2 Antigen Test by WHPM Inc.. 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. T.
Details
Source
Device Recall
External ID
Z-0892-2022
Action Date
2022-04-13
Status
Terminated
Category
device
Product Description
First SIGN SARS-CoV-2 Antigen Test
Lot/Code Info: Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041;
Quantity Affected: 535,755 tests
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.
Distribution
U.S.: CA, FL, LA, MA and TX O.U.S.: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-04
Company
Irwindale, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (WHPM Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does WHPM Inc. have FDA actions?
This is the only FDA action we have on record for WHPM Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0892-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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