Agency classClass IIOur severity:High FDA (Devices)·Z-0875-2023·Announced 2023-01-11

FDA Recalls PPM Lombard TSA Culture Medium Due to Storage Temperature Exceedance

Biomerieux Inc. is recalling PPM Lombard culture medium because the product was exposed to temperature and time conditions outside specification, potentially affecting test 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 3/5 (High).

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: FDA Class II recall of a medical device with no reported illnesses or injuries. The product is a culture medium where performance cannot be guaranteed due to storage condition exceedance. This constitutes a risk-of-harm product where injury has not yet been reported, meeting the criterion for High severity.

Plain-English summary

Biomerieux Inc. is recalling PPM Lombard Products TSA (32ML), Catalog M1205-IR, Batch Number 1009497920. TSA (Trypticase Soy Agar) is a culture medium classified as a medical device used in laboratory testing.

The product is being recalled because it was stored or transported under temperature and time conditions exceeding the product's specifications. When storage conditions fall outside specification, the manufacturer cannot guarantee the product will perform as intended.

The recalled product has been distributed nationwide in the United States. Laboratories and other facilities that received this product should discontinue use and contact Biomerieux Inc. for replacement or instructions on proper disposition of the product.

The recalled product

Product: PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
Manufacturer: Biomerieux Inc
Category: Medical Device — Laboratory Culture Medium
Hazard: temperature-exceedance
time-exceedance
performance-failure
Affected units: 12

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 03573026320706
Batch Numbers: 1009497920

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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Same hazard · temperature exceedance