ETEST Clinical Ceftolozane/Tazobactam Antibiotic Susceptibility Test Recalled for Temperature Excursion
Biomerieux is recalling ETEST Clinical Ceftolozane/Tazobactam S30 diagnostic tests (batch 1009420460) due to storage temperature and time excursions. Product performance cannot be guaranteed, and test accuracy may be affected.
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 recall for a diagnostic test where storage excursions prevent guaranteeing product performance, creating a potential risk of inaccurate antibiotic susceptibility testing that could affect clinical decision-making. No illnesses or injuries have been reported.
Plain-English summary
Biomerieux Inc is recalling ETEST Clinical Ceftolozane/Tazobactam C/T US S30 diagnostic tests due to storage condition failure. The recall involves 6 units with batch number 1009420460, catalog number 414445, and UDI/DI 03573026418748. The product was distributed nationwide.
During storage and handling, the product was exposed to temperature and time conditions outside the specified range. As a result, the manufacturer cannot guarantee that the product will perform as intended, and test accuracy may be compromised.
Healthcare facilities and clinical laboratories that received units from this batch should contact Biomerieux Inc for instructions regarding the recalled product.
The recalled product
- Product
- ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445
- Manufacturer
- Biomerieux Inc
- Affected units
- 6
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 03573026418748
- Batch Numbers: 1009420460
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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