Nanosphere Recalls Verigene CDF Amplification Trays Due to Increased Error Rates
Nanosphere is recalling specific lots of Verigene CDF Amplification Trays because they produced an increased rate of 'No Call - INT CTL 2' results when testing negative samples.
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 III, which by definition is unlikely to cause adverse health consequences. The issue is a technical error rate in the diagnostic test rather than a direct physical hazard or reported illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Nanosphere, Inc. is recalling 280 sets of Verigene CDF Amplification Trays, Catalog Number 20-011-022. The affected lots are 061913022D and 071813022E. These trays are components of the Verigene CDF Amplification Reagent Kit (20-012-022), which is used in the Verigene Clostridium difficile Nucleic Acid Test (CDF). The CDF test is an in vitro diagnostic used to detect specific gene sequences in stool specimens from patients suspected of having C. difficile infection.
The recall was initiated after Nanosphere received reports of an increased rate of 'No Call - INT CTL 2' results for the Internal Control 2 (INT CTL 2) when negative samples were tested with the affected lots. This specific error indicates a potential issue with the internal control mechanism of the test.
The affected products were distributed in the United States, including the states of California and Washington. The source text does not specify the exact number of affected units beyond the 280 sets of trays, nor does it report any illnesses or injuries associated with the use of these products. Users of the affected lots should stop using them and contact Nanosphere for further instructions.
The recalled product
- Product
- Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of tox
- Manufacturer
- Nanosphere, Inc.
- Hazard
- Affected units
- 280
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)
- Verigene CDF Amplification Trays
- Catalog Number: 20-011-022
- Lot Numbers: 061913022D and 071813022E
Distribution
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