Biomerieux BIOBALL B.SPIZIZENII culture products recalled for storage failure
Biomerieux is recalling BIOBALL B.SPIZIZENII NCTC 10400 (Catalog 56012) microbiological test cultures because storage temperature and time conditions 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 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 recalls with no reported illnesses, injuries, or deaths are rated Moderate. This recall addresses a storage-handling issue affecting product performance rather than posing an acute health risk.
Plain-English summary
Biomerieux Inc is recalling BIOBALL B.SPIZIZENII NCTC 10400 550X20 (Catalog 56012), a microbiological test culture product distributed nationwide in the United States. Batch 7190 is affected by this recall.
The recall was initiated because the storage temperature and time conditions exceeded the specified parameters for these products. Biomerieux states that due to these out-of-range storage conditions, product performance cannot be guaranteed.
Users who have received the affected products should discontinue use of batch 7190 and contact Biomerieux Inc for additional guidance or product replacement.
The recalled product
- Product
- BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012
- Manufacturer
- Biomerieux Inc
- Hazard
- 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 03573026228200
- Batch Numbers: 7190
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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