Biomerieux Inc: VITEK 2 AST Test Kits Recalled for False Antibiotic Susceptibility Results

Agency Publication Date: April 25, 2024

Summary

Biomerieux Inc is recalling approximately 49,215 VITEK 2 - AST test kits because some recently manufactured cards have errors in the concentration of the antibiotic Ceftriaxone. These test kits are used in clinical laboratories to determine which antibiotics will be effective against a patient's infection. Due to this defect, the kits may incorrectly show that a bacterial infection is susceptible to treatment (meaning the drug would work) when it is actually resistant, potentially leading to ineffective medical treatment for patients. Consumers should contact their healthcare provider or the manufacturer regarding these diagnostic kits.

Risk

The concentration errors in the test cards can produce false 'susceptible' results for certain bacterial isolates. If a physician relies on these incorrect results, they may prescribe Ceftriaxone to treat an infection that is actually resistant to the drug, leading to treatment failure and serious health complications.

What You Should Do

Identify if your laboratory or healthcare facility is using VITEK 2 - AST Test kits by checking the REF (Reference) and Lot numbers on the packaging.
Check for the following affected Reference 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, and 424721.
Verify your specific lot numbers against the extensive list of affected lots, which include codes such as 7742790503, 6852740103, 6892721103, 1402832104, 1512776404, 0422750104, and others listed in the product documentation.
Immediately stop using the affected test kits for isolates that have a Minimum Inhibitory Concentration (MIC) result of 0.5, 1, or 2.
Contact Biomerieux Inc at 1-800-634-7656 or visit their website to receive further technical instructions and potential replacement information.
If you are a patient and believe your treatment was based on a VITEK 2 susceptibility test, contact your healthcare provider to discuss your clinical results.
For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Technical Guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: VITEK 2 - AST-N334

Model / REF:

REF 418984

UDI/DI 3573026490720

Lot Numbers:

7742790503

7742805403

7742828503

7742830203

Product: VITEK 2 - AST-GN95

Model / REF:

REF 421982

UDI/DI 3573026565923

Lot Numbers:

6852740103

6852751503

6852778503

6852811503

Product: VITEK 2 - AST-GN99

Model / REF:

REF 423102

UDI/DI 3573026608132

Lot Numbers:

6892721103

6892727403

6892740503

6892740403

6892743503

6892761503

6892770403

6892790103

6892799403

6892799103

6892810103

6892818103

6892831503

Product: VITEK 2 - AST-N390

Model / REF:

REF 423340

UDI/DI 3573026612177

Lot Numbers:

1402832104

1402761504

Product: VITEK 2 - AST-N391

Model / REF:

REF 423341

UDI/DI 3573026612269

Lot Numbers:

1412831104

1412754504

Product: VITEK 2 - AST-N392

Model / REF:

REF 423342

UDI/DI 3573026612283

Lot Numbers:

1422819204

Product: VITEK 2 - AST-N395

Model / REF:

REF 423491

UDI/DI 3573026615802

Lot Numbers:

1452725204

Product: VITEK 2 - AST-N401

Model / REF:

REF 423643

UDI/DI 3573026616816

Lot Numbers:

1512776404

1512789204

1512811104

1512831104

1512720404

1512729404

1512729104

1512748504

1512754104

1512785404

Product: VITEK 2 - AST-N402

Model / REF:

REF 423644

UDI/DI 3573026616830

Lot Numbers:

1522720504

1522733404

Product: VITEK 2 - AST-N404

Model / REF:

REF 423664

UDI/DI 3573026617356

Lot Numbers:

1542819204

Product: VITEK 2 - AST-N802

Model / REF:

REF 423706

UDI/DI 3573026617752

Lot Numbers:

0422750104

0422763104

0422764504

0422782404

0422820504

0422820404

Product: VITEK 2 - AST-N405

Model / REF:

REF 423864

UDI/DI 3573026621360

Lot Numbers:

1552757504

1552792404

1552800404

1552820104

1552733104

1552741504

1552757404

Product: VITEK 2 - AST-N417

Model / REF:

REF 423880

UDI/DI 3573026621704

Lot Numbers:

0192763504

0192819404

Product: VITEK 2 - AST-N408

Model / REF:

REF 423924

UDI/DI 3573026622725

Lot Numbers:

1582810504

1582820104

1582734404

1582742504

1582764404

1582782504

Product: VITEK 2 - AST-N409

Model / REF:

REF 423925

UDI/DI 3573026622749

Lot Numbers:

1592811104

1592746404

Product: VITEK 2 - AST-N420

Model / REF:

REF 424039

UDI/DI 3573026625283

Lot Numbers:

0462810404

Product: VITEK 2 - AST-N423

Model / REF:

REF 424042

UDI/DI 3573026625337

Lot Numbers:

0502750404

0502825504

Product: VITEK 2 - AST-N422

Model / REF:

REF 424056

UDI/DI 3573026625610

Lot Numbers:

0482819504

Product: VITEK 2 - AST-N436

Model / REF:

REF 424440

UDI/DI 3573026631666

Lot Numbers:

0672734104

0672754104

Product: VITEK 2 - AST-N809

Model / REF:

REF 424703

UDI/DI 3573026635978

Lot Numbers:

0962799404

Product: VITEK 2 - AST-N806

Model / REF:

REF 424709

UDI/DI 3573026636067

Lot Numbers:

0932729404

Product: VITEK 2 - AST-N807

Model / REF:

REF 424710

UDI/DI 3573026636081

Lot Numbers:

0942723404

Product: VITEK 2 - AST-N808

Model / REF:

REF 424711

UDI/DI 3573026636104

Lot Numbers:

0952758104

Product: VITEK 2 - AST-N810

Model / REF:

REF 424712

UDI/DI 3573026636128

Lot Numbers:

0972729504

Product: VITEK 2 - AST-N812

Model / REF:

REF 424721

UDI/DI 3573026636296

Lot Numbers:

0992777104

0992776504

0992821404

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94264

Status: Active

Manufacturer: Biomerieux Inc

Sold By: Biomerieux Inc; medical supply distributors

Manufactured In: United States

Units Affected: 49215 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify if your laboratory or healthcare facility is using VITEK 2 - AST Test kits by checking the REF (Reference) and Lot numbers on the packaging.

Check for the following affected Reference 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, and 424721.

Verify your specific lot numbers against the extensive list of affected lots, which include codes such as 7742790503, 6852740103, 6892721103, 1402832104, 1512776404, 0422750104, and others listed in the product documentation.

Immediately stop using the affected test kits for isolates that have a Minimum Inhibitory Concentration (MIC) result of 0.5, 1, or 2.

Contact Biomerieux Inc at 1-800-634-7656 or visit their website to receive further technical instructions and potential replacement information.

If you are a patient and believe your treatment was based on a VITEK 2 susceptibility test, contact your healthcare provider to discuss your clinical results.

For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: VITEK 2 - AST-N334

Model / REF:

REF 418984

UDI/DI 3573026490720

Lot Numbers:

7742790503

7742805403

7742828503

7742830203

Product: VITEK 2 - AST-GN95

Model / REF:

REF 421982

UDI/DI 3573026565923

Lot Numbers:

6852740103

6852751503

6852778503

6852811503

Product: VITEK 2 - AST-GN99

Model / REF:

REF 423102

UDI/DI 3573026608132

Lot Numbers:

6892721103

6892727403

6892740503

6892740403

6892743503

6892761503

6892770403

6892790103

6892799403

6892799103

6892810103

6892818103

6892831503

Product: VITEK 2 - AST-N390

Model / REF:

REF 423340

UDI/DI 3573026612177

Lot Numbers:

1402832104

1402761504

Product: VITEK 2 - AST-N391

Model / REF:

REF 423341

UDI/DI 3573026612269

Lot Numbers:

1412831104

1412754504

Product: VITEK 2 - AST-N392

Model / REF:

REF 423342

UDI/DI 3573026612283

Lot Numbers:

1422819204

Product: VITEK 2 - AST-N395

Model / REF:

REF 423491

UDI/DI 3573026615802

Lot Numbers:

1452725204

Product: VITEK 2 - AST-N401

Model / REF:

REF 423643

UDI/DI 3573026616816

Lot Numbers:

1512776404

1512789204

1512811104

1512831104

1512720404

1512729404

1512729104

1512748504

1512754104

1512785404

Product: VITEK 2 - AST-N402

Model / REF:

REF 423644

UDI/DI 3573026616830

Lot Numbers:

1522720504

1522733404

Product: VITEK 2 - AST-N404

Model / REF:

REF 423664

UDI/DI 3573026617356

Lot Numbers:

1542819204

Product: VITEK 2 - AST-N802

Model / REF:

REF 423706

UDI/DI 3573026617752

Lot Numbers:

0422750104

0422763104

0422764504

0422782404

0422820504

0422820404

Product: VITEK 2 - AST-N405

Model / REF:

REF 423864

UDI/DI 3573026621360

Lot Numbers:

1552757504

1552792404

1552800404

1552820104

1552733104

1552741504

1552757404

Product: VITEK 2 - AST-N417

Model / REF:

REF 423880

UDI/DI 3573026621704

Lot Numbers:

0192763504

0192819404

Product: VITEK 2 - AST-N408

Model / REF:

REF 423924

UDI/DI 3573026622725

Lot Numbers:

1582810504

1582820104

1582734404

1582742504

1582764404

1582782504

Product: VITEK 2 - AST-N409

Model / REF:

REF 423925

UDI/DI 3573026622749

Lot Numbers:

1592811104

1592746404

Product: VITEK 2 - AST-N420

Model / REF:

REF 424039

UDI/DI 3573026625283

Lot Numbers:

0462810404

Product: VITEK 2 - AST-N423

Model / REF:

REF 424042

UDI/DI 3573026625337

Lot Numbers:

0502750404

0502825504

Product: VITEK 2 - AST-N422

Model / REF:

REF 424056

UDI/DI 3573026625610

Lot Numbers:

0482819504

Product: VITEK 2 - AST-N436

Model / REF:

REF 424440

UDI/DI 3573026631666

Lot Numbers:

0672734104

0672754104

Product: VITEK 2 - AST-N809

Model / REF:

REF 424703

UDI/DI 3573026635978

Lot Numbers:

0962799404

Product: VITEK 2 - AST-N806

Model / REF:

REF 424709

UDI/DI 3573026636067

Lot Numbers:

0932729404

Product: VITEK 2 - AST-N807

Model / REF:

REF 424710

UDI/DI 3573026636081

Lot Numbers:

0942723404

Product: VITEK 2 - AST-N808

Model / REF:

REF 424711

UDI/DI 3573026636104

Lot Numbers:

0952758104

Product: VITEK 2 - AST-N810

Model / REF:

REF 424712

UDI/DI 3573026636128

Lot Numbers:

0972729504

Product: VITEK 2 - AST-N812

Model / REF:

REF 424721

UDI/DI 3573026636296

Lot Numbers:

0992777104

0992776504

0992821404