Advandx E. coli/P. aeruginosa PNA FISH Kit Recalled for Cross-Reactivity
Advandx Inc is recalling 33 units of the E. coli/P. aeruginosa PNA FISH kit because Pseudomonas putida strains may cross-react, causing false-positive results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. While the rubric typically associates Class II with 'Severe' (score 4) when hospitalizations are reported, this recall involves a diagnostic error (false positive) without reported injuries or hospitalizations. Per the rubric, risk-of-harm products where injury has not yet been reported fall under 'High' (score 3).
Plain-English summary
Advandx Inc is recalling 33 units of the AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit (Catalog Number KT007). The recall affects lot numbers 01812A-US, 03412A-US, and 00512A-EU, all with an expiration date of 12-2013. The product was distributed nationwide in the United States, specifically in California, Florida, Illinois, Michigan, and New Jersey, as well as in Great Britain.
The recall was initiated because some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in the kit. This sequence similarity can result in a cross-reaction that produces a red-positive signal, potentially leading to misidentification of the bacteria in blood cultures. The kit is intended for the identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods.
Healthcare facilities and laboratories that have received these specific lots should stop using the product and contact Advandx Inc for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for ide
- Manufacturer
- Advandx Inc
- Affected units
- 33
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 (2)
- Lot Numbers: 01812A-US
- 03412A-US and 00512A-EU Exp Date: 12-2013
Distribution
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