Opgen Recalls GNR PNA FISH Control Slides Due to Performance Issues
Opgen Inc is recalling 80 GNR PNA FISH Control Slides because they may show diminished performance before expiration, potentially causing invalid test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to diminished performance leading to invalid test results, which fits the criteria for a moderate severity score.
Plain-English summary
Opgen Inc is recalling 80 units of the CS011 GNR PNA FISH Control Slide, which is a component of the CS011-10 GNR PNA FISH Control Slide kit. These in-vitro diagnostic slides are used to provide positive and negative controls for the KT011 GNR Traffic Light PNA FISH kit, which identifies specific bacteria in blood cultures.
The recall was initiated because the control slides may show diminished performance prior to their established expiration date. This issue can result in an invalid control result for the associated PNA FISH test. The affected lot number is FN80107.
The product was distributed in the United States to the states of Connecticut, Michigan, and Virginia. Users of this product should stop using the affected slides and contact Opgen Inc for further instructions or a replacement.
The recalled product
- Product
- CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic…
- Manufacturer
- Opgen Inc
- Hazard
- Affected units
- 80
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 Number FN80107
Distribution
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