FDA-Device2021-08-18Class II
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Beckman Coulter Inc.
Hazard
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Sold states
US Nationwide Distribution in the states of Alabama Alaska Arizona Arkansas California Connecticut Delaware Florida Georgia Idaho Illinois Indiana Iowa Kentucky Louisiana Maine Maryland Massachusetts Michigan Mississippi New Hampshire New Jersey New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico Tennessee Texas Virginia West Virginia, Wisconsin OUS: New Zealand, Libya
Affected count
3,672 unitsin total
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2255-2021Don't want to check this manually?
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