FDA-Device2021-06-02Class II
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Beckman Coulter Inc.
Hazard
specimens collected in transport media may result is false negative results when stored in certain conditions.
Sold states
Worldwide distribution - US Nationwide distribution in the states of Alabama, 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 and the country of New Zealand.
Affected count
1,034 units
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1670-2021Don't want to check this manually?
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