Culture Medium Recall Due to Temperature Excursion Affecting Product Performance
Biomerieux Inc recalls PPM INDUSTRY COMBOURG LPT BROTH culture medium batches 2117760 and 2120100 due to temperature excursion that may compromise product performance and reliability.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The hazard is compromised product performance due to temperature excursion, representing a risk-of-harm scenario where diagnostic accuracy cannot be assured, fitting the High severity category.
Plain-English summary
Biomerieux Inc is recalling PPM INDUSTRY COMBOURG LPT BROTH (4X3L) culture medium, a microbiological culture medium product (UDI/DI: 03573026357849). Batches 2117760 and 2120100 are affected and were distributed nationwide.
The recall was initiated because temperatures and storage duration exceeded specified ranges during handling and storage. When storage conditions exceed these specifications, the chemical and biological properties of the culture medium may degrade, and the manufacturer cannot guarantee product performance or that it will function as intended.
Affected customers nationwide who received these batches should discontinue use of the product immediately. Contact Biomerieux Inc for instructions on replacement product or proper disposition of affected batches.
If any testing or diagnostic work was performed using product from the affected batches, results should be considered potentially unreliable pending retesting with replacement product.
The recalled product
- Product
- PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849
- Manufacturer
- Biomerieux Inc
- Affected units
- 4
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 (3)
- UDI/DI 03573026357849
- Batch Numbers: 2117760
- 2120100
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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