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WHPM Inc. Recall 89676

Description: First SIGN SARS-CoV-2 Antigen Test

WHPM Inc. Recall 89676 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0892-2022
Event ID89676
Event DescriptionFirst SIGN SARS-CoV-2 Antigen Test
Product TypeDevices
DistributionU.S.: CA, FL, LA, MA and TX O.U.S.: N/A
Quantity535,755 tests
Recall ReasonFrm 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.
Device Classification20220413
Device Code InfoModel Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041;
Center Classification Date20220407
Recall Initiation Date20220304
Recalling FirmWHPM Inc.
Initial Notification Letter
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