Hardy Diagnostics Recalls GBS Detect Test Kits Due to Performance Failure
Hardy Diagnostics is recalling GBS Detect test kits because product deterioration causes poor hemolytic reactions, potentially leading to inaccurate detection of Group B Streptococcus.
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: The recall is classified as FDA Class II, and the source text describes a performance failure due to product deterioration without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Hardy Diagnostics is voluntarily recalling 3,530 units of GBS Detect (Cat no. A300) test kits. The recall is due to a performance failure where the product deteriorates, resulting in a poor hemolytic reaction when tested against the target quality control organism, Streptococcus agalactiae (ATCC 13813). This issue affects the ability to accurately isolate and detect gamma-hemolytic (non-hemolytic) Group B Streptococcus.
The affected products are from lots H16054 and H15056. These units were distributed in the United States to the following states: Alabama, South Carolina, Florida, Connecticut, Virginia, Wisconsin, Massachusetts, Michigan, West Virginia, Ohio, Indiana, Illinois, North Carolina, and Texas.
Healthcare facilities and laboratories should stop using the affected test kits and contact Hardy Diagnostics for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
- Manufacturer
- Hardy Diagnostics
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 (1)
- Lot H16054 and H15056.
Distribution
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