Biomerieux VITEK 2 AST-N461 test kit recalled for card pouch damage causing false antibiotic resistance results
What this means
Some units of the Biomerieux VITEK 2 AST-N461 test kit used to determine antibiotic susceptibility in gram-negative bacteria have damaged card pouches. This damage can cause the test to report false resistant results, which may lead to use of less effective antibiotics or unnecessary antibiotic combinations.
- Check if your laboratory received units from lot 1333393504 (UDI-DI 03573026637712)
- Do not use affected units for patient testing
- Contact Biomerieux for replacement units or further instructions
- Review any patient results from this lot for accuracy
The agency's original wording
The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3231-2026Want us to check the next one for you?
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