Biomerieux recalled 2,668,954 VITEK 2 Gram-negative susceptibility cards on January 5, 2026. The recall addresses potential false resistant results for certain antibiotic tests. Healthcare providers and patients must stop using the product immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Biomerieux Inc or your healthcare provider for instructions. Notification method: Letter
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The recall includes all lot codes of the VITEK 2 Gram-negative susceptibility cards. The affected products were distributed worldwide, including the United States.
The recall addresses a potential risk of quality control failures and false resistant antibiotic results when testing specific bacterial isolates. This issue could lead to incorrect treatment decisions.
There are no specific injury counts reported related to this recall. The risk arises from possible false results during antibiotic susceptibility testing.
Stop using the VITEK 2 susceptibility cards immediately. Contact Biomerieux Inc or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1236-2026.
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