Laboratory Testing Product Recall Due to Temperature Storage Excursion
Biomerieux Inc is recalling PPM Lombard Products TSA 3P W Neutralizers due to storage temperature and time excursions that degrade product performance. Affected units cannot guarantee reliable testing results.
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 involving a laboratory testing product with no reported illnesses, injuries, or hospitalization. The hazard is precautionary and performance-based—storage excursion affecting product accuracy—rather than an immediate safety threat.
Plain-English summary
Biomerieux Inc is recalling PPM Lombard Products TSA 3P W Neutralizers (Catalog 419014, UDI 03573026493868) due to temperature and time storage conditions that exceeded specified ranges. This product is used in laboratory testing and quality assurance applications.
Because temperature and time conditions were out of range, product performance cannot be guaranteed. This affects the accuracy and reliability of test results obtained using the affected units.
Seven (7) units were distributed nationwide in the United States under batch number 1009498140.
The recalled product
- Product
- PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014
- Manufacturer
- Biomerieux Inc
- Affected units
- 7
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 03573026493868
- Batch Numbers: 1009498140
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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