FDA-Device2017-12-27Class II
ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
BioMerieux SA
Hazard
QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.
Sold states
Worldwide Distribution - USA (nationwide) and to the countries of : Algeria, Austria, Australia, Belarus, Bosnia-Herz., Canada, Croatia, Czech Republic, Egypt, Estonia, France, Georgia, Germany, Greece, Guam, Hong Kong, Hungary, India, Israel, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlands, Nigeria, Peru, Philippines, Qatar, Russian Fed., Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Utd.Arab Emir.
Affected count
1585 units
Manufactured in
Chemin De L'Orme, Marcy L'Etoile, France
Products
ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0264-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief