Class I FDA device recall · Z-1464-2024

Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.

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

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide

Recall record

Recalling firm: Biomerieux Inc
Product type: Devices
Recall number: Z-1464-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: E-Mail
Origin: Hazelwood, MO
Recall initiated: 2024-03-14

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1464-2024 · Source: openFDA enforcement.