ETEST Clinical Erythromycin test plates recalled for storage temperature deviation
Biomerieux Inc is recalling ETEST Clinical Erythromycin EM 256 US S30 test plates (batch 1009157090) distributed nationwide. Product performance cannot be guaranteed due to temperature and time storage conditions that exceeded specifications.
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 an FDA Class II medical device where product performance cannot be guaranteed due to storage condition deviation. The product is a risk-of-harm device used for clinical testing, but no illnesses or injuries have been reported.
Plain-English summary
Biomerieux Inc is recalling ETEST Clinical Erythromycin EM 256 US S30 test plates, catalog 412333, batch 1009157090. The recalled quantity is 5 units, distributed nationwide in the United States.
The product is being recalled because temperature and time storage conditions for the affected batch exceeded the specified parameters. Because these conditions were exceeded, product performance cannot be guaranteed.
Laboratories and healthcare facilities that received the affected product should discontinue use of batch 1009157090 and contact Biomerieux Inc for recall instructions and replacement product.
The recalled product
- Product
- ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
- Manufacturer
- Biomerieux Inc
- Affected units
- 5
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 03573026377557
- Batch Numbers: 1009157090
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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