Clinical Diagnostic Device Recall: ETEST Rifampicin RI 32 Performance Degradation
Biomerieux Inc is recalling ETEST CLINICAL RIFAMPICIN RI 32 clinical diagnostic strips because temperature and time storage parameters were exceeded, and product performance cannot be guaranteed.
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 product performance cannot be guaranteed due to storage failures. No illnesses or injuries have been reported, but unreliable diagnostic test results could potentially affect patient care decisions.
Plain-English summary
Biomerieux Inc is recalling ETEST CLINICAL RIFAMPICIN RI 32 US S30, Catalog 412449, a clinical diagnostic device. The recall includes 2 units with Batch Number 1009190620, distributed nationwide throughout the United States.
The recall was initiated because the products were stored outside acceptable temperature and time parameters. According to the manufacturer, product performances cannot be guaranteed as a result of these storage condition failures.
The recalled product
- Product
- ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
- 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 03573026378592
- Batch Numbers: 1009190620
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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