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.
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: 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
- Hazard
- storage-temperature-excursion
- product-performance-loss
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.
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