Recall Z-0618-2019 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
bioMerieux, Inc.
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, bet
| Date | Oct 22, 2018 |
| Status | Terminated |
| Reason | False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported. |
| Root cause | Component change control |
| Action | 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.