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.
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 3/5 (High).
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…
- 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
Related recalls
Same manufacturer · Advandx Inc
See all →- ModerateAdvandx Quick FISH Fixation Kit Recalled for Quality Control Failure
FDA (Devices) · 2014-08-13
- LowAdvanDx Gram-Negative QuickFISH BC Kits Recalled for Microscope Incompatibility
FDA (Devices) · 2014-01-08
- ModerateAdvandx GNR Traffic Light PNA FISH Kit Recalled for False Positives
FDA (Devices) · 2012-10-31
Same hazard · false positive result
See all →- ModerateAlere Recalls hCG Pregnancy Tests Due to False Positive Risk
FDA (Devices) · 2026-10-07
- ModerateAlere hCG Urine Test Strips Recalled for False Positive Risk
FDA (Devices) · 2026-10-07
- HighAlere hCG Pregnancy Test Cassettes Recalled for False Positive Results
FDA (Devices) · 2026-10-07
- HighSequencing Agent SEQ0067 Component Recalled for Potential False-Positive Results
FDA (Devices) · 2026-04-29
- HighStratus CS Acute Care cTNI TestPak cardiac troponin test recall
FDA (Devices) · 2025-05-07
Similar recalls
- ModerateAdvandx GNR Traffic Light PNA FISH Kit Recalled for False Positives
FDA (Devices) · 2012-10-31
- LowAdvanDx Gram-Negative QuickFISH BC Kits Recalled for Microscope Incompatibility
FDA (Devices) · 2014-01-08
- ModerateAdvandx Quick FISH Fixation Kit Recalled for Quality Control Failure
FDA (Devices) · 2014-08-13
- HighDiagnostic Kit Recalled for False Positive Bacterial Identification Results
FDA (Devices) · 2022-12-07
- HighAccelerate PhenoTest BC Kit Recall Due to False Positive Bacterial Identification
FDA (Devices) · 2022-12-07
- ModerateEpigenomics Recalls Epi proColon Plasma Quick Kit Due to Invalid Test Runs
FDA (Devices) · 2018-03-28