Z-0618-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2018
- Initiation Date
- October 22, 2018
- Termination Date
- November 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 184,374
Product Description
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.
Reason for Recall
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY including Puerto Rico and to countries of:Algeria, Angola, Azerbaijan, Bahrain, Bangladesh, Belarus, Sarl, Benin, Bosnia-Herz, Cameroon, Chad, Cote d'Ivoire, Croatia, Dem. Rep. Congo, Egypt, , Georgia, Guam, Ethiopia, Iraq, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, UAB, Lithuania, Macedonia, Malta, Mongolia, Morocco, Mozambique, Niger, Oman, Pakistan, Palestine, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, Sri Lanka, Tunisia, Ukraine, Gabon, and Zimbabwe.
Code Information
Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03