Open, Classified

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 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p) AST-N420, REF 424039; q) AST-N423, REF 424042; r) AST-N422, REF 424056; s) AST-N436, REF 424440; t) AST-N809, REF 424703; u) AST-N806, REF 424709; v) AST-N807, REF 424710; w) AST-N808, REF 424711; x) AST-N810, REF 424712; y) AST-N812, REF 424721

FDA Recall Z-1464-2024 · Posted 2024-04-25

Recall StatusOpen, Classified

Product CodeLON

Date Initiated2024-03-14

Product Quantity49215 units

Reason for Recall

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.

Firm 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."

Root Cause

Employee error

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161217VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)bioMerieux, Inc. · 2017-01-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.