PlainRecalls
FDA Devices Moderate Class II Terminated

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 ins

Reported: December 26, 2018 Initiated: October 22, 2018 #Z-0618-2019

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.

Details

Recalling Firm
bioMerieux, Inc.
Units Affected
184,374
Distribution
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.
Location
Durham, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by bioMerieux, Inc.. Units affected: 184,374.
Why was this product recalled?
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 26, 2018. Severity: Moderate. Recall number: Z-0618-2019.