FDA-Device2018-06-20Class II
remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).
Thermo Fisher
Hazard
Product may fail performance testing for S aureus ATCC 43300.
Sold states
US Nationwide Distribution
Affected count
67 units
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2137-2018Don't want to check this manually?
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