Agency classClass IIOur severity:High FDA (Devices)·Z-0830-2023·Announced 2023-01-11

ETEST Tobramycin Susceptibility Test Recalled for Storage Condition Failure

Biomerieux is recalling ETEST Clinical Tobramycin susceptibility test strips (batch 1009434160) because temperature and storage time conditions were exceeded during distribution. Product performance cannot be guaranteed due to these storage failures.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device recall without reported illnesses or injuries. The compromised storage conditions create a risk of diagnostic performance loss, but no adverse effects have been reported. Per the rubric, recalls with theoretical risks but no reported harm score 3 (High).

Plain-English summary

Biomerieux Inc is recalling the ETEST Clinical Tobramycin TM 256 US S30 (catalog 412478), a bacterial susceptibility test strip used to determine antibiotic resistance in clinical specimens. The recall affects batch number 1009434160.

The recall was initiated because temperature and storage time conditions exceeded specifications during product distribution. According to the manufacturer, product performance cannot be guaranteed as a result of these storage condition exceedances.

The affected product was distributed nationwide throughout the United States.

The recalled product

Product: ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478
Manufacturer: Biomerieux Inc
Category: Medical Device — Diagnostic Test
Hazard: improper-storage
performance-failure
Affected units: 4

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 03573026378875
Batch Numbers: 1009434160

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 · improper storage