ETEST Clinical Amoxicillin/Clavulanic Acid Test System Recalled Due to Storage Excursion
Biomerieux Inc is recalling ETEST CLINICAL AMOXI/CLAV 2/1 XL test systems nationwide (batch 1009311920) due to temperature and time storage excursions that may affect product performance.
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: This is a Class II medical device recall where storage excursions have compromised product integrity and performance cannot be guaranteed. Although no illnesses or injuries have been reported, this represents a risk-of-harm situation where diagnostic test accuracy could be affected, potentially leading to incorrect clinical decisions.
Plain-English summary
Biomerieux Inc is recalling the ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30 test system (catalog 412252, batch 1009311920) from nationwide distribution.
The recall was initiated because temperature and time storage parameters were exceeded during product handling or storage. As a result, the product's performance cannot be guaranteed. These test systems are used for antibiotic susceptibility testing in clinical and diagnostic laboratory settings.
The recalled product was distributed nationwide. Affected laboratories and healthcare facilities should discontinue use of the affected batch and contact Biomerieux Inc for replacement or proper disposition.
No illnesses or injuries related to this recall have been reported to the FDA.
The recalled product
- Product
- ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
- Manufacturer
- Biomerieux Inc
- Affected units
- 2
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 03573026376703
- Batch Numbers: 1009311920
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 →Related recalls
Same manufacturer · Biomerieux Inc
See all →- HighBiomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
Same hazard · storage excursion
See all →- ModerateHemoCue glucose microcuvettes experienced transit time outside of specified limits
FDA (Devices) · 2025-07-09
- HighAbbott Diagnostics ARC T-Uptake Assay Reagent Recalled for Storage Excursion
FDA (Devices) · 2025-06-04
- HighOrtho Clinical Diagnostics Vancomycin Reagent Cold Chain Recall
FDA (Devices) · 2025-06-04
- ModerateHemoCue Glucose Control Kit Affected by Improper Storage During Transit
FDA (Devices) · 2025-06-04
- ModerateAbbott Point of Care Creatinine Test Cartridges Recalled for Storage Failure
FDA (Devices) · 2025-06-04
Similar recalls
- ModerateBioMerieux Recalls Ceftriaxone ETEST Kits Due to Performance Issues
FDA (Devices) · 2017-05-31
- HighBioMerieux Recalls ETEST Oxacillin Strips Due to Quality Control Failures
FDA (Devices) · 2017-12-27
- ModerateBioMerieux Recalls ETEST Ciprofloxacin CI 32 Foam Due to Stability Issues
FDA (Devices) · 2017-03-29
- LowBiomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date
FDA (Devices) · 2014-11-26
- LowBiomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date Labeling
FDA (Devices) · 2014-11-26
- HighBioMerieux Etest Cefotaxime CT 256 In Vitro Diagnostic Recall
FDA (Devices) · 2015-07-08