ETEST Clinical Eravacycline ERV test kit recalled for temperature storage excursion
Biomerieux is recalling ETEST Clinical Eravacycline ERV test kits nationwide after temperature and time storage conditions exceeded acceptable ranges, making product performance unreliable.
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 risk-of-harm product where functional performance has been compromised due to storage excursions. Though no illnesses have been reported, loss of guaranteed performance in an FDA Class II medical device indicates potential for adverse health consequences through unreliable test results.
Plain-English summary
Biomerieux is recalling ETEST Clinical Eravacycline ERV US S30 (catalog 421553) nationwide. The recall affects batch number 1009288050.
The product was exposed to temperatures and time periods outside acceptable ranges. When stored under these conditions, the manufacturer states that product performances cannot be guaranteed.
Customers who have received the affected product should immediately discontinue its use. Healthcare facilities and other customers should contact Biomerieux for instructions on obtaining replacement product or credit.
For additional information about this recall, visit the FDA website at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-0851-2023
The recalled product
- Product
- ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553
- 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 03573026560997
- Batch Numbers: 1009288050
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 temperature excursion
See all →- ModerateBD Microbiology Fluid Thioglycollate Medium Tubes Recall
FDA (Devices) · 2025-06-04
- ModerateAbbott Diagnostics ARCH AUSAB Anti-HBS Reagent Recall
FDA (Devices) · 2025-06-04
- HighVITEK 2 AST-GP67 Reagent Test Kit Recalled Due to Storage Condition Excursion
FDA (Devices) · 2023-01-11
- HighVITEK 2 AST-XN15 Test Kit Recalled for Temperature and Time Storage Failure
FDA (Devices) · 2023-01-11
- HighETEST Vancomycin Susceptibility Test Recalled Due to Storage Damage
FDA (Devices) · 2023-01-11
Similar recalls
- ModerateBioMerieux Recalls Ceftriaxone ETEST Kits Due to Performance Issues
FDA (Devices) · 2017-05-31
- LowBiomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date Labeling
FDA (Devices) · 2014-11-26
- HighbioMerieux Recalls VITEK 2 AST-N351 Test Kits Due to False Positives
FDA (Devices) · 2019-02-27
- 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
- LowDiamedix EBV Test Kit Recalled for Gel-Like Contaminant
FDA (Devices) · 2018-08-08