FDA Recalls Antibiotic Susceptibility Test Strips Due to Storage Condition Excursion
Biomerieux Inc is recalling ETEST antibiotic susceptibility test strips due to storage temperature and time excursions that may affect test performance. No illnesses or injuries have been reported.
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: Class II FDA recall for diagnostic device where storage excursion may affect test accuracy. Diagnostic inaccuracy presents risk of patient harm through misdiagnosis or inappropriate treatment decisions, though no illnesses or injuries have been reported.
Plain-English summary
Biomerieux Inc is recalling the ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30 antibiotic susceptibility test strips (Catalog 412240) due to storage condition excursions. The affected product experienced temperature and time conditions outside the required range during handling or storage, which may compromise the performance and reliability of the test strips.
The affected batch (1009190560) was distributed nationwide throughout the United States. These test strips are used in clinical laboratory settings to determine bacterial susceptibility to antibiotics and guide antibiotic treatment decisions.
Laboratories and healthcare facilities that have received this product should stop using the affected batch and contact Biomerieux Inc for instructions on replacement or proper disposition. No illnesses or injuries have been reported.
The recalled product
- Product
- ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240
- Manufacturer
- Biomerieux Inc
- Hazard
- storage-excursion
- diagnostic-inaccuracy
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 03573026376581
- Batch Numbers: 1009190560
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03