Summary: BioMérieux is recalling an antimicrobial sensitivity testing kit after discovering an excess concentration of the antibiotic Ceftriaxone, which may cause serious adverse health consequences.


  1. The VITEK 2 AST cards were found to have a higher concentration of Ceftriaxone antibiotic in two wells.
  2. The use of these faulty kits may result in serious health consequences such as extended hospital stays, unnecessary medical procedures, treatment failures, and severe infections like sepsis.
  3. BioMérieux has advised customers to consider alternative methods for determining the minimal inhibitory concentration (MIC) if results fall within certain ranges, and has issued guidelines on handling the recall.

BioMérieux is recalling its VITEK 2 AST cards, an antimicrobial sensitivity testing kit, due to a higher concentration of Ceftriaxone antibiotic in two wells, says the U.S. Food and Drug Administration (FDA). This kit is used for testing how sensitive bacteria are to antibiotics. 

Recalling the Antimicrobial Sensitivity Test Kit

Some of the cards have more of the antibiotic Ceftriaxone in two of their wells than they should. BioMérieux is telling customers about this issue and suggesting they use a different testing method if the results show that the MIC (minimal inhibitory concentration) is in a range of 0.5, 1, 2, according to the FDA.

The use of the affected kit may cause serious adverse health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and death, says the FDA. There have been no reports of injuries or deaths associated with this issue.

Further reading: How Metagenomic Sequencing Identifies Antimicrobial Resistance in Bloodstream Infections

Use of the VITEK AST Test

The VITEK 2 AST kit, which includes the Gram-negative Susceptibility Card, is a test used to figure out how susceptible certain types of bacteria are to antibiotics. Each card has different antibiotics in it, dried with a special material for growing bacteria. The VITEK 2 machine watches how the bacteria grow in each well on the card for a set amount of time. Then, it gives results showing the minimal inhibitory concentration (MIC) for most combinations of bacteria and drugs, along with whether the bacteria are susceptible (S), intermediate (I), or resistant (R) to the antibiotics.

What’s Next?

On March 15, 2024, bioMérieux sent all affected customers an Urgent Field Safety Notice. 

The letter requested customers to: 

  • Continue using the kits with consideration of alternative method to determine MIC, if this method results in MIC of 0.5, 1, 2.
  • Distribute this information to all appropriate personnel, retain a copy of this letter, and forward this information to all parties that may use this product, including others to whom may have received this product.
  • Store this notice letter with the bioMérieux VITEK 2 documentation.
  • Complete the Acknowledgement Form included and return it to [email protected] to confirm receipt of this notice.

Photo: bioMérieux