Laboratory Culture Medium Recalled Due to Storage Condition Failure
Biomerieux Inc is recalling PPM Lombard Products IRR Count-Tact 3P Agar because storage conditions exceeded acceptable temperature and time parameters, potentially compromising 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 an FDA Class II recall for a laboratory culture medium where storage conditions were exceeded. No illnesses or injuries have been reported, and the hazard is impaired product performance rather than direct injury risk.
Plain-English summary
Biomerieux Inc is recalling PPM Lombard Products IRR Count-Tact 3P Agar 100 PLT (Catalog 418049, UDI/DI 03573026466435) due to storage conditions that exceeded acceptable temperature and time parameters.
When temperature and time storage conditions are exceeded, the product's performance cannot be guaranteed. Affected laboratory units may not perform reliably for their intended diagnostic or analytical use.
The recalled product was distributed nationwide in the United States. The affected batch number is 1009462900. If you have received this product, do not use it. Contact Biomerieux Inc for return instructions or replacement.
The recalled product
- Product
- PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049
- Manufacturer
- Biomerieux Inc
- Affected units
- 8
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 03573026466435
- Batch Numbers: 1009462900
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.
See all 94 products in this recall →Related recalls
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