VITEK 2 — Class I medical device recall Z-1464-2024
Ongoing recall by Biomerieux Inc, reported 2024-05-01. Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would
| Recall number | Z-1464-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2024-03-14 |
| Classified | 2024-04-25 |
| Reported by FDA | 2024-05-01 |
| Quantity | 49,215 units |
| UPC / GTIN / UDI-DI | 03573026490720, 03573026565923, 03573026608132, 03573026612177, 03573026612269, 03573026612283, 03573026615802, 03573026616816, 03573026616830, 03573026617356, 03573026617752, 03573026621360, 03573026621704, 03573026622725, 03573026622749, 03573026625283, 03573026625337, 03573026625610, 03573026631666, 03573026635978, 03573026636067, 03573026636081, 03573026636104, 03573026636128, 03573026636296 |
| Serial numbers | 0192763504, 0192819404, 0422750104, 0422763104, 0422764504, 0422782404, 0422820404, 0422820504, 0462810404, 0482819504, 0502750404, 0502825504, 0672734104, 0672754104, 0932729404, 0942723404, 0952758104, 0962799404, 0972729504, 0992776504, 0992777104, 0992821404, 1402761504, 1402832104, 1412754504 and 52 more |
| Model numbers | 418984, 421982, 423102, 423340, 423341, 423342, 423491, 423643, 423644, 423664, 423706, 423864, 423880, 423924, 423925, 424039, 424042, 424056, 424440, 424703, 424709, 424710, 424711, 424712, 424721 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1464-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.