FDA-Device2021-04-21Class II
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
Becton Dickinson & Co.
Hazard
BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty rehydration buffer tube may lead to an Unresolved (UNR) result on the BD MAX" System
Sold states
US Nationwide
Affected count
21,529 Kits
Manufactured in
7 Loveton Cir, N/A, Sparks, MD, United States
Products
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1416-2021Don't want to check this manually?
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