FDA-Device2017-09-06Class II
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
Biomerieux Inc
Hazard
Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.
Sold states
Worldwide
Affected count
1866 units
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3075-2017Don't want to check this manually?
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