Recall Z-1464-2024 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Biomerieux Inc
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; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 4238
| Date | Apr 25, 2024 (initiated Mar 14, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Employee error |
| Action | BioMerieux issued an URGENT FIELD SAFETY NOTICE to its consignees on 03/14/2024 via email. The notice explained the issue, impact to patient, and provided the consignee (user) with alternate testing methods. BioMerieux issued another URGENT FIELD SAFETY NOTICE dated 07MAY2024 to its consignees on May 9, 2024, via email. This letter includes the statement, "however, no results for the Ceftriaxone (cro02n) should be reported outside the lab." |
| Quantity | 49215 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161217 | VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) bioMerieux, Inc., Jan 12, 2017 |