Advandx GNR Traffic Light PNA FISH Kit Recalled for False Positives
Advandx Inc is recalling 187 GNR Traffic Light PNA FISH kits because they may produce false positive results for Pseudomonas putida and Pseudomonas fulva.
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, and the hazard involves potential diagnostic errors (false positives) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Advandx Inc is recalling 187 units of the AdvanDx GNR Traffic Light PNA FISH In Vitro Diagnostic for Culture Identification Kit (Catalog number: KT011). The recall covers specific lot numbers with expiration dates ranging from December 2013 to April 2014. The product was distributed nationwide in the United States and in Austria, Denmark, Italy, Germany, Finland, and the UK.
The recall was initiated because the assay may produce false positive results when used to identify Pseudomonas putida and Pseudomonas fulva. The GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli, Klebsiella pneumoniae, and/or Pseudomonas aeruginosa on smears from positive blood cultures. It is indicated for use as an aid in the diagnosis of bacteremia caused by these specific organisms.
Healthcare facilities and laboratories that have received these kits should stop using the affected lots and contact Advandx Inc for instructions on how to return or dispose of the product. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization…
- Manufacturer
- Advandx Inc
- Affected units
- 187
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)
- Lot Numbers: 02012A-US Exp. Date: 4-2014
- 0812A-US Exp. Date: 12-2013
- 01212A-EU Exp. Date: 4-2012 00712A-EU Exp. Date: 12-2013
Distribution
Distributed nationwide across the United States.
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