Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0874-2023·Announced 2023-01-11

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.

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: 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
Category: Medical Device — Laboratory Culture Medium
Hazard: storage-condition
performance-degradation
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.

See all 94 products in this recall →

Same manufacturer · Biomerieux Inc

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