Medical device TSA culture medium recalled due to storage temperature excursion
Biomerieux Inc. is recalling PPM Lombard TSA culture medium nationwide due to storage temperature excursion. The product may not perform to specification.
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: This is a Class II FDA recall with no reported illnesses or injuries. The hazard is theoretical—product performance cannot be guaranteed due to storage temperature and time excursions—meeting the criteria for Moderate severity.
Plain-English summary
Biomerieux Inc. is recalling PPM Lombard Products TSA 10PLT (Catalog M1040) with batch number 1009527240. The product was distributed nationwide in the United States.
The recall was initiated because the product was exposed to temperatures and durations outside the manufacturer's specifications. As a result, the manufacturer cannot guarantee that the product will perform as intended.
Users of this product should discontinue use and contact Biomerieux Inc. for instructions regarding replacement or alternative products.
The recalled product
- Product
- PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
- Manufacturer
- Biomerieux Inc
- Hazard
- performance-degradation
- storage-condition-failure
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 03573026320362
- Batch Numbers: 1009527240
Distribution
Distributed nationwide across the United States.
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