VITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk

Plain-English summary

Biomerieux Inc is recalling specific VITEK 2 AST (Antimicrobial Susceptibility Test) test kits distributed worldwide. These are in vitro diagnostic test cards used in laboratory testing to determine bacterial resistance to antibiotics. Twenty-five different catalog numbers are affected, comprising 49,215 units total, with specific lot and serial numbers identified by the FDA.

The affected test kits contain ceftriaxone concentration errors in recently manufactured units. These errors could produce false susceptible results, meaning the test could incorrectly indicate that bacteria are susceptible to the antibiotic. The risk is present for isolates with minimum inhibitory concentration (MIC) values of 0.5, 1, or 2.

Healthcare facilities and diagnostic laboratories that use these test kits should verify their inventory against the lot and serial numbers provided. A complete listing of affected catalog numbers, reference numbers, UDI/DI codes, and specific lot/serial numbers is available from the FDA.

The recalled product

Product

VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491;

Manufacturer

Biomerieux Inc

Category

Medical Device — Diagnostic Test Kit

Hazard

• ceftriaxone-concentration-error
• false-susceptible-results

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distribution scope not specified by the agency.

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