Bioball Fungal Reference Standard Recalled for Temperature Storage Issues
Biomerieux Inc. recalled 2 units of BIOBALL A.BRASILIENSIS NCPF 2275 reference standard (Batch 7112) after temperature and time storage conditions exceeded acceptable ranges. The manufacturer cannot guarantee 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: This is a Class II recall with no reported illnesses, injuries, or documented product failures. The hazard is precautionary, based on storage condition exceedances that may compromise product performance reliability. Per the rubric, voluntary precautionary recalls without reported incidents rate as Moderate.
Plain-English summary
Biomerieux Inc. is recalling BIOBALL A.BRASILIENSIS NCPF 2275 550X20 (Catalog 56011), a microbiological reference standard used in quality control and testing applications. The recall affects 2 units distributed nationwide in the United States.
The recall was initiated because the product experienced storage conditions that exceeded acceptable temperature and time parameters. When storage conditions fall outside the specified range, the manufacturer cannot guarantee that the product will perform as intended for its intended purpose.
Users of Batch 7112 (UDI/DI 03573026228194) should contact Biomerieux Inc. to verify whether they received affected units. Laboratories should confirm the storage history and conditions of any units in their possession before continued use in quality control applications.
The recalled product
- Product
- BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011
- 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 03573026228194
- Batch Numbers: 7112
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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