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Recall Observatory FDA recall evidence

Device product

First SIGN SARS-CoV-2 Antigen Test

Z-0892-2022

March 04, 2022

Class II

Product summary

Firm
WHPM Inc.
Event
Event 89676
Status
Terminated
Classification
Class II
Quantity
535,755 tests
Official record key
device-enforcement:Z-0892-2022

Official wording

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.

Code information: Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041;

Distribution pattern: U.S.: CA, FL, LA, MA and TX O.U.S.: N/A

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.