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 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

Recall number

Z-1464-2024

Recalling firm

Biomerieux Inc

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

Status

Open, Classified

Initiated

2024-03-14

Posted

2024-04-25

Terminated

not on file

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

Lot, serial or model codes

a) AST-N334, REF 418984, UDI/DI 3573026490720, Lot/Serial Numbers: 7742790503, 7742805403, 7742828503, 7742830203; b) AST-GN95, REF 421982, UDI/DI 3573026565923, Lot/Serial Numbers: 6852740103, 6852751503, 6852778503, 6852811503; c) AST-GN99, REF 423102, UDI/DI 3573026608132, Lot/Serial Numbers: 6892721103, 6892727403, 6892740503, 6892740403, 6892743503, 6892761503, 6892770403, 6892790103, 6892799403, 6892799103, 6892810103, 6892818103, 6892831503; d) AST-N390, REF 423340, UDI/DI 3573026612177, Lot/Serial Numbers: 1402832104, 1402761504; e) AST-N391, REF 423341, UDI/DI 3573026612269, Lot/Serial Numbers: 1412831104, 1412754504; f) AST-N392, REF 423342, UDI/DI 3573026612283, Lot/Serial Numbers: 1422819204; g) AST-N395, REF 423491, UDI/DI 3573026615802, Lot/Serial Numbers: 1452725204; h) AST-N401, REF 423643, UDI/DI 3573026616816, Lot/Serial Numbers: 1512776404, 1512789204, 1512811104, 1512831104, 1512720404, 1512729404, 1512729104, 1512748504, 1512754104, 1512785404; i) AST-N402, REF 423644, UDI/DI 3573026616830, Lot/Serial Numbers: 1522720504, 1522733404; j) AST-N404, REF 423664, UDI/DI 3573026617356, Lot/Serial Numbers: 1542819204; k) AST-N802, REF 423706, UDI/DI 3573026617752, Lot/Serial Numbers: 0422750104, 0422763104, 0422764504, 0422782404, 0422820504, 0422820404; l) AST-N405, REF 423864, UDI/DI 3573026621360, Lot/Serial Numbers: 1552757504, 1552792404, 1552800404, 1552820104, 1552733104, 1552741504, 1552757404; m) AST-N417, REF 423880, UDI/DI 3573026621704, Lot/Serial Numbers: 0192763504, 0192819404; n) AST-N408, REF 423924, UDI/DI 3573026622725, Lot/Serial Numbers: 1582810504, 1582820104, 1582734404, 1582742504, 1582764404, 1582782504; o) AST-N409, REF 423925, UDI/DI 3573026622749, Lot/Serial Numbers: 1592811104, 1592746404; p) AST-N420, REF 424039, UDI/DI 3573026625283, Lot/Serial Numbers: 0462810404; q) AST-N423, REF 424042, UDI/DI 3573026625337, Lot/Serial Numbers: 0502750404, 0502825504; r) AST-N422, REF 424056, UDI/DI 3573026625610, Lot/Serial Numbers: 0482819504; s) AST-N436, REF 424440, UDI/DI 3573026631666, Lot/Serial Numbers: 0672734104, 0672754104; t) AST-N809, REF 424703, UDI/DI 3573026635978, Lot/Serial Numbers: 0962799404; u) AST-N806, REF 424709, UDI/DI 3573026636067, Lot/Serial Numbers: 0932729404; v) AST-N807, REF 424710, UDI/DI 3573026636081, Lot/Serial Numbers: 0942723404; w) AST-N808, REF 424711, UDI/DI 3573026636104, Lot/Serial Numbers: 0952758104; x) AST-N810, REF 424712, UDI/DI 3573026636128, Lot/Serial Numbers: 0972729504; y) AST-N812, REF 424721, UDI/DI 3573026636296, Lot/Serial Numbers: 0992777104, 0992776504, 0992821404

510(k) numbers

["K161217"]

PMA numbers

not on file

Product code

LON

Firm FEI

1950204

Firm city

Hazelwood

Firm state

MO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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