Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0821-2023·Announced 2023-01-11

ETEST Ceftriaxone Antibiotic Test Strips Recalled for Storage Condition

Biomerieux is recalling ETEST Clinical Ceftriaxone test strips nationwide because storage temperature and time conditions were exceeded, which may affect product analytical performance.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall with no reported illnesses, injuries, or analytical failures. The hazard is theoretical—storage excursion may compromise performance but no actual clinical incidents have been reported. The source explicitly states the condition creates uncertainty rather than confirmed damage, making this a precautionary recall.

Plain-English summary

Biomerieux Inc is recalling ETEST Clinical Ceftriaxone TX 32 US S30 antibiotic susceptibility test strips (Catalog 412302, Batch 1009444340) due to storage conditions that exceeded acceptable temperature and time parameters.

These diagnostic test strips are used in clinical laboratories to determine bacterial susceptibility to ceftriaxone antibiotic therapy. When stored outside the specified temperature and time range, the product's analytical performance cannot be guaranteed.

The product was distributed nationwide to clinical laboratories. Biomerieux recommends that healthcare facilities using affected batch numbers verify the integrity and accuracy of any test results generated using this product and consider retesting if applicable.

Users should contact Biomerieux with questions about affected inventory or proper handling and disposal of recalled product.

The recalled product

Product: ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
Manufacturer: Biomerieux Inc
Category: Medical Device — Clinical Diagnostic / Antibiotic Susceptibility Testing
Hazard: analytical-performance
storage-condition
Affected units: 1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UDI/DI 03573026377205
Batch Numbers: 1009444340

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 94 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 94 products in this recall →

Same manufacturer · Biomerieux Inc

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Same hazard · analytical performance