ETEST Antibiotic Susceptibility Test Kit Recalled for Storage Degradation
Biomerieux Inc recalled ETEST antibiotic susceptibility test kits from batch 1009384490 due to storage conditions exceeding safe temperature and time parameters, potentially affecting test accuracy.
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 with no reported illnesses or injuries. The product is a diagnostic device where accuracy directly impacts clinical decision-making; storage-related degradation poses risk of unreliable test results, fitting the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Biomerieux Inc recalled ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30 test kits (Catalog 419046, UDI 03573026494537) from Batch 1009384490 distributed nationwide in the United States. This diagnostic device is used in clinical laboratories to test antibiotic susceptibility of bacteria and help guide antibiotic treatment selection.
The recall was initiated because storage conditions exceeded the temperature and time parameters specified for the product. When storage conditions fall outside specifications, the product's performance and ability to provide accurate results cannot be guaranteed.
Clinical laboratories that possess units from affected batch 1009384490 should stop using them and contact Biomerieux Inc for guidance on replacement or proper disposal. Laboratories should review their quality control records and may need to reconsider or retest any patient samples tested using affected kits.
The recalled product
- Product
- ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046
- Manufacturer
- Biomerieux Inc
- Affected units
- 8
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 03573026494537
- Batch Numbers: 1009384490
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.
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