WHPM Inc.: Medical Device Recall in 2022 - (Recall #: Z-0892-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

First SIGN SARS-CoV-2 Antigen Test

Product Classification:

Class II

Date Initiated: March 4, 2022

Date Posted: April 13, 2022

Recall Number: Z-0892-2022

Event ID: 89676

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.

Status: Terminated

Product Quantity: 535,755 tests

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

Voluntary or Mandated:

Voluntary: Firm initiated