Reported May 1, 2024 · Ongoing
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility)
Biomerieux Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320
Is this the product you have?
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility)
25 of 25 products
| Model / number | Product as published |
|---|---|
418984 | AST-N334 |
421982 | AST-GN95 |
423102 | AST-GN99 |
423340 | AST-N390 |
423341 | AST-N391 |
423342 | AST-N392 |
423491 | AST-N395 |
423643 | AST-N401 |
423644 | AST-N402 |
423664 | AST-N404 |
423706 | AST-N802 |
423864 | AST-N405 |
423880 | AST-N417 |
423924 | AST-N408 |
423925 | AST-N409 |
424039 | AST-N420 |
424042 | AST-N423 |
424056 | AST-N422 |
424440 | AST-N436 |
424703 | AST-N809 |
- Amount recalled
- 49215 units
Why it was recalled
Stop using this product now
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
Using this product could cause serious injury, illness or death — stop using it now.
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