—#168666

Product

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.

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03

Why it was recalled

False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.

Root cause (FDA determination)

Component change control

Action the firm took

The Firm, Biomerieux, issued a " URGENT Product Correction Notice" to their consignees informing of the matter and providing certain actions for them to take. Each Notice will be accompanied with an Acknowledge Form which is to be returned to bioMerieux.. The consignees were instructed to take the following action at this time: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " Reference your Laboratory Standard Operating Procedures to identify card types and breakpoints used in your facility to determine if your laboratory is impacted by the issue described in this letter. " Reference your Laboratory Standard Operating Procedures to identify if retrospective analysis is required for reported results associated with the referenced limitation. " For systems utilizing EUCAST breakpoints and operating with VITEK 2 Systems Software version 8.01, create a bioART Rule for the referenced limitation associated with Ceftriaxone (cro01n). " Please store this letter with your bioMrieux instrument documentation. -Please complete the attached Acknowledgement Form (Attachment A) and return it to bioMrieux, Inc. If you have any questions or concerns, please contact your local bioMrieux representative or call , Regulatory Quality Compliance Specialist, at 314-731-8805 or email: debra.broyles@biomerieux.com.

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

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.

Timeline

Recall initiated: 2018-10-22
Terminated: 2019-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168666. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.