Helix Elite Molecular Standards recalled due to shelf life test failure
Microbiologics Inc is recalling Helix Elite Molecular Standards for Inactivated Influenza A/B and Respiratory Syncytial Virus because shelf life testing failed at 24 months, potentially affecting product stability.
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: This is an FDA Class II recall of a diagnostic reference material that failed shelf life testing. The hazard is a risk-of-harm product where no illnesses or injuries have been reported, and the stability failure represents a theoretical risk to diagnostic reliability rather than documented harm.
Plain-English summary
Microbiologics Inc is recalling Helix Elite Molecular Standards: Inactivated Standard (Inactivated Influenza A/B and Respiratory Syncytial Virus), Catalog Number HE0044N, Lot Number HE0044N-103-1. These reference materials are used in molecular testing.
Real-time shelf life testing failed at 24 months, indicating the product may not maintain its intended stability and performance characteristics beyond that timeframe.
The product was distributed worldwide, including throughout the United States (Alaska, California, Washington DC, Florida, Iowa, Idaho, Kansas, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, and West Virginia) and to Australia, Belgium, Canada, India, and the United Kingdom.
Customers with this product should discontinue use. No illnesses or injuries have been reported.
The recalled product
- Product
- Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
- Manufacturer
- Microbiologics 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 (3)
- Catalog Number: HE0044N
- Lot Number: HE0044N-103-1
- UDI: 10845357042184
Distribution
Part of a larger recall action
This product is one of 5 recalled by Microbiologics 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.
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