Biomerieux Inc: VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

Is my product affected?

VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

• UPC 03573026637712

Check against the official notice below — it lists the full affected range.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: International distribution to the countries of Austria, Germany, Luxembourg. Quantity: 97680 units Lot/code info: UDI-DI 03573026637712; Lot Number 1333393504

Source

Official record: FDA (Device enforcement) ↗

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

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