FDA-Device2022-03-16Class II
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Remel Inc
Hazard
There are lower than expected MICs for some gram negative species.
Sold states
Distribution throughout the United States.
Affected count
1210 devices
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0722-2022Don't want to check this manually?
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