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.
What this means for you
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
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.
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