Microbiologics QC Panel Recalled Due to Shelf Life Testing Failure
Microbiologics Inc is recalling its Helix Elite Extended Enteric Bacterial Verification Panel because real-time shelf life testing failed at 24 months.
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 a Class II medical device recalled due to failed shelf life testing with no reported illnesses, injuries, or documented performance failures in use. The recall is precautionary, based on product functionality concerns rather than a documented safety hazard.
Plain-English summary
Microbiologics Inc is recalling the Helix Elite Extended Enteric Bacterial Verification Panel, a Class II medical device consisting of 21 inactivated pellets. Each pellet contains eight bacterial organisms used for laboratory testing verification.
The recall is prompted by real-time shelf life testing that failed at 24 months, indicating the product did not maintain its expected performance characteristics beyond that timeframe.
The product was distributed worldwide, including to locations 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 internationally (Australia, Belgium, Canada, India, and the United Kingdom). The affected product is identified by Catalog Number 8191, Lot Number 8191-01, and UDI 70845357041240.
The recalled product
- Product
- Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derive
- Manufacturer
- Microbiologics Inc
- Hazard
- Affected units
- 8
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: 8191
- Lot Number: 8191-01
- UDI: 70845357041240
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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