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.
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: 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
- Hazard
- temperature-exceedance
- time-exceedance
- performance-failure
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.
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