Biomerieux Inc: VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam

Hazard

Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.

Details from the source

Reason for recall: Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results. Distribution: Worldwide - US Nationwide distribution. Quantity: 2,668,954 total Lot/code info: All lot codes of the identified Gram-negative AST test kits.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.