Helix Elite Molecular Standard Fails FDA Shelf-Life Stability Testing
Microbiologics Inc. recalls Helix Elite Inactivated Neisseria gonorrhoeae Strain GL0071 molecular standard after real-time shelf life testing failed at 24 months. The product was distributed nationwide and internationally.
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 a Class II FDA device with no reported illnesses or injuries. The product failed shelf-life validation, making it a risk-of-harm product where the hazard is theoretical rather than documented. Per the rubric, theoretical hazards without reported harm score at most 3.
Plain-English summary
Microbiologics Inc. is recalling Helix Elite Inactivated Neisseria gonorrhoeae Strain GL0071, a molecular standard used for diagnostic testing. The FDA classified this as a Class II recall after the product failed real-time shelf life stability testing at 24 months.
The affected product has Catalog Number HE0041N and Lot Number HE0041N-102-1. The product was distributed nationwide across the United States and internationally to Australia, Belgium, Canada, India, and the United Kingdom.
Healthcare laboratories and facilities that have received this product should refer to official FDA and manufacturer communications for further guidance and handling instructions.
The recalled product
- Product
- Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
- 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: HE0041N
- Lot Number: HE0041N-102-1
- UDI: 10845357042153
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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