PPM Clinical Chromid VRE Culture Media Recalled for Storage Excursion
Biomerieux is recalling PPM Clinical Craponne Chromid VRE culture media because storage conditions (temperature and time) exceeded specifications. Batch 1009540400 was 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: This is a Class II medical device recall issued due to storage conditions exceeding specifications. No illnesses, injuries, or actual product failures have been reported. The hazard is theoretical—a quality or performance issue—consistent with voluntary precautionary recalls.
Plain-English summary
Biomerieux Inc is recalling PPM Clinical Craponne Chromid VRE 20 PLT US (Catalog 43851), Batch Number 1009540400 (UDI/DI 03573026313128). The recall was issued because temperature and time storage conditions exceeded specification limits during distribution or storage.
When storage conditions exceed the specified ranges for temperature and time, the manufacturer cannot guarantee that the product will perform as intended.
The affected product was distributed nationwide throughout the United States.
The recalled product
- Product
- PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
- Manufacturer
- Biomerieux Inc
- 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 03573026313128
- Batch Numbers: 1009540400
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 →Related recalls
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