FDA-Device2017-05-31Class II

Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba

BioMerieux SA
Hazard

Potential performance issue on strain categorization.

Sold states
USA (nationwide) Distribution to the states of : AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, ME, MA, MI, MN, MO, MT, NH, NY, NC, OR, PA, SC, SD, TN, TX, WA
Affected count
4656 kits
Manufactured in
Chemin De L'Orme, Marcy L'Etoile, France
Products
Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2126-2017

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