WHPM Inc. Recall 89676
Description: First SIGN SARS-CoV-2 Antigen Test
WHPM Inc. Recall 89676 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0892-2022 |
Event ID | 89676 |
Event Description | First SIGN SARS-CoV-2 Antigen Test |
Product Type | Devices |
Distribution | U.S.: CA, FL, LA, MA and TX O.U.S.: N/A |
Quantity | 535,755 tests |
Recall 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. |
Device Classification | 20220413 |
Device Code Info | Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041; |
Center Classification Date | 20220407 |
Recall Initiation Date | 20220304 |
Recalling Firm | WHPM Inc. |
Initial Notification | Letter |
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