Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0873-2023·Announced 2023-01-11

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.

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 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
Category: Medical Device — Laboratory / Culture Medium
Hazard: performance-degradation
storage-condition-failure
Affected units: 1

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.

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 →

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