PPM Lombard R2A Laboratory Medium Recalled for Exceeded Storage Conditions
Biomerieux Inc is recalling PPM Lombard R2A medium products (lot 1009527290) because storage conditions exceeded acceptable parameters, compromising product performance. Approximately 20 units distributed nationwide in the United States.
What this means for you
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 recall with no reported illnesses, injuries, or hospitalizations. The hazard is functional—storage condition exceedance that may degrade product performance—rather than an acute safety risk. Class II recalls without reported harm are typically scored as Moderate (2) per the rubric.
Plain-English summary
Biomerieux Inc is recalling the PPM Lombard Products R2A Medium (Catalog M1065, lot 1009527290, UDI/DI 03573026320485). The product was stored under conditions that exceeded acceptable temperature and time parameters. Due to these storage condition exceedances, product performance cannot be guaranteed.
The recalled product was distributed nationwide in the United States, affecting approximately 20 units.
Healthcare providers and laboratory personnel who have received this product should discontinue use and contact Biomerieux Inc for replacement or instructions. Users should verify whether their stored units are from the recalled batch (1009527290) and take appropriate action if affected.
The recalled product
- Product
- PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065
- Manufacturer
- Biomerieux Inc
- Affected units
- 20
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 03573026320485
- Batch Numbers: 1009527290
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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