FDA-Device2024-05-01Class I
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p
Hazard
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
Sold states
Worldwide
Affected count
49215 units
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p) AST-N420, REF 424039; q) AST-N423, REF 424042; r) AST-N422, REF 424056; s) AST-N436, REF 424440; t) AST-N809, REF 424703; u) AST-N806, REF 424709; v) AST-N807, REF 424710; w) AST-N808, REF 424711; x) AST-N810, REF 424712; y) AST-N812, REF 424721
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1464-2024Don't want to check this manually?
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