FDA-Device2015-08-19Class II
PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
Remel Inc
Hazard
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Sold states
Nationwide Distribution, including Puerto Rico and the country of Canada.
Affected count
4420 bottles
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2351-2015Don't want to check this manually?
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