FDA-Device2021-02-10Class II
SARS-CoV-2 Antigen Test
Qiagen Sciences LLC
Hazard
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Sold states
Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY
Affected count
1092 boxes of 60 (65,520 e-sticks)
Manufactured in
19300 Germantown Rd, Germantown, MD, United States
Products
SARS-CoV-2 Antigen Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0941-2021Don't want to check this manually?
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