CHROMID MRSA Culture Medium Recalled for Storage Temperature Exceedance
Biomerieux Inc is recalling PPM CLINICAL CHROMID MRSA 20 PLT diagnostic culture media (84 units) due to temperature and time exceedance during storage that may compromise product performance.
What this means for you
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 an FDA Class II recall involving potential diagnostic performance degradation due to storage condition exceedance. No illnesses, injuries, or hospitalizations have been reported. The hazard is theoretical—improper storage may compromise diagnostic accuracy—but actual harm has not been documented.
Plain-English summary
Biomerieux Inc has recalled PPM CLINICAL CHROMID MRSA 20 PLT US, catalog number 43841, a selective culture medium used for the isolation and identification of methicillin-resistant Staphylococcus aureus (MRSA). The recall affects 84 units with batch numbers 1009525720 and 1009530050 distributed nationwide in the United States.
The manufacturer initiated the recall because these units were exposed to temperature and time conditions that exceeded acceptable storage parameters during distribution or storage. As a result, the manufacturer cannot guarantee the product's performance and reliability as intended.
Healthcare facilities and clinical laboratories that received these products are affected by this recall. The recalled product was intended for use in clinical microbiology to support MRSA detection and identification.
Users of the recalled CHROMID MRSA medium should immediately discontinue use of the affected batches and contact Biomerieux Inc for information regarding replacement or reimbursement options.
The recalled product
- Product
- PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841
- Manufacturer
- Biomerieux Inc
- Hazard
- diagnostic-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 (3)
- UDI/DI 03573026313111
- Batch Numbers: 1009525720
- 1009530050
Distribution
Distributed nationwide across the United States.
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