FDA-Device2022-05-25Class II
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Luminex Corporation
Hazard
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
Sold states
US
Affected count
984 units
Manufactured in
4088 Commercial Ave, N/A, Northbrook, IL, United States
Products
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1109-2022Don't want to check this manually?
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