Biomerieux Recalls BIOBALL K.RHIZOPHILA Diagnostic Kits Due to Storage Failure
Biomerieux Inc recalls BIOBALL K.RHIZOPHILA diagnostic kits (batch 7408) due to exceeded temperature and time storage conditions that may compromise 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device recalled due to storage condition failure. No illnesses or injuries reported. The hazard is theoretical—product performance degradation—consistent with a precautionary recall triggered by quality control findings rather than actual patient harm.
Plain-English summary
Biomerieux Inc is recalling BIOBALL K.RHIZOPHILA (30X20), Catalog 412690, a diagnostic microbial identification product used in clinical and laboratory settings. The recall affects two units distributed nationwide in the United States.
The recall was initiated because storage temperature and time conditions were exceeded during handling or storage. When these parameters exceed acceptable ranges, the manufacturer cannot guarantee the product's performance in diagnostic testing.
Affected facilities that received units with UDI/DI 03573026381103, Batch 7408 should discontinue use and contact Biomerieux Inc for return or replacement instructions.
The recalled product
- Product
- BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690
- 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 03573026381103
- Batch Numbers: 7408
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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