Microbiologics Inc. is recalling 580 packages of its Enteric Pathogens Control Panel (Inactivated Pellet) due to contamination. The negative control pellet, which should not contain any viral material, was found to be contaminated with Norovirus. This defect can cause the laboratory test to incorrectly report a positive Norovirus result when it should be negative, potentially leading to incorrect patient diagnosis or medical decisions. Consumers should contact the manufacturer or their healthcare provider for further instructions.
The contamination causes the diagnostic test to give a false positive result for Norovirus. This can lead to patients receiving unnecessary treatments or being subjected to isolation and infection control measures for a virus they do not actually have.
Manufacturer notification and guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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