Device Recall Etest

1002774320, 1002377890, 1002590470, 1002775330, 1002379610

Immunology and Microbiology Devices

2

No

Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.

Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.

Ref. 412433, Lot numbers: 1004394540, 1003903640, 1003558430, 1003069250, 1002372580 and 1001938220

Immunology and Microbiology Devices

2

No

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.

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.

Ref. 521418, Lot numbers: 1004398470, 1004276460, 1004180840, 1003980200, 1003699550, 1003416920, 1003105180, 1002995820, 1002482640, 1002375410, 1002276210 and 1002092270.

Immunology and Microbiology Devices

2

No

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.

Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. || Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

Ref. 521458, Lot numbers: 1004397280, 1004271100, 1003977350, 1003903650, 1003561810, 1003239850, 1002489700, 1002273480, 1002216620 and 1002120370.

Immunology and Microbiology Devices

2

No

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.

Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. || Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

Reference no. 525550, Lot #1001094650, 1001136230, 1001212920, 1001293800, 1001302920, 1001319720, 1001334090, 1001391310, 1001430030, 1001518060 & 1001686190; Reference no. 525558, Lot #1001174720, 1001251340, 1001334100, 1001368020, 1001442000, 1001566840, 1001647970, 1001734920, 1001761450, 1001761480, 1001897000, 1001898600, 1002008040, 1002073480, 1002197270, 1002282890, 1002338820, 1002365880, 1002443950, 1002465840, 1002558040, 1002562240, 1002733640, 1002751340, 1003171920, 1003449250, 1003679000, 1003836080, 1004040220, 1004121870, 1004151340, 1004173130, 1004256780, 1004264340, 1004371500, 1004491190, 1004509340, 1004564470, 1004775890, 1004913990, 1004980270, 1005027170, 1005132320, 1005186480, 1004735790, 1004767430, 1004775900, 1004914010, 1004980280, 1005027180 & 1005132340; Reference no. 525510, Lot #1001051200, 1001125840, 1001416930, 1001455150, 1001548250 & 1001596090 and Reference no. 525518, Lot #1001192860, 1001223460, 1001317000, 1001338170, 1001416940, 1001416950, 1001492590, 1001566860, 1001634070, 1001728340, 1001761460, 1001887350, 1001894800, 1002007990, 1002045080, 1002113290, 1002197250, 1002287970, 1002338070, 1002369060, 1002440920, 1002463490, 1002496690, 1002565090, 1002583690, 1002604690, 1002663860, 1002809200, 1002809880, 1002876470, 1002922750, 1003079740, 1003134480, 1003373510, 1003621540, 1003778630, 1003809630, 1003910700, 1003972790, 1004052410, 1004121860, 1004150380, 1004256770, 1004371490, 1004496990, 1004508060, 1004564470, 1004775890, 1004913990, 1004980270, 1005027170, 1005132320 & 1005186480.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions