# FDA recall Z-1464-2024

> **Biomerieux Inc** · Class I · device recall initiated 2024-03-14.

## 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;   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

## 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.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-1464-2024
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-14
- **Report date:** 2024-05-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hazelwood, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1464-2024

## Citation

> AI Analytics. FDA recall Z-1464-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1464-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*