FDA-Device2015-12-30Class I

Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

Biomerieux
Hazard

Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.

Sold states
Worldwide Distribution- US Nationwide including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GS, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV and WY, and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Lithuania, Malaysia, Macedonia, Oman, Netherlands, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Singapore, Slavonia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, the United Kingdom, Vietnam and Venezuela.
Affected count
1216 units
Manufactured in
69280 Marcy, N/A, Letoile, N/A, France
Products
Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0440-2016

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