AdvanDx Gram-Negative QuickFISH BC Kits Recalled for Microscope Incompatibility
AdvanDx is recalling Gram-Negative QuickFISH BC kits because they are incompatible with certain fluorescence microscope light sources.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
AdvanDx, Inc. is recalling the AdvanDx Gram-Negative QuickFISH BC in-vitro diagnostic kits. The recall is due to the kits being incompatible with certain fluorescence microscope light sources. The affected product is used for the rapid identification of specific bacteria, including Escherichia coli, Pseudomonas aeruginosa, and Klebsiella pneumoniae, directly from Gram-negative-positive blood cultures.
The recall involves 49 kits distributed in the United States and 17 kits distributed outside the United States. The United States distribution includes California, Illinois, Indiana, Ohio, New Jersey, Michigan, Missouri, New York, and Wisconsin. The kits were also distributed internationally to Denmark. Specific lot codes for the United States are 04813C, 7413, and 08113 with an expiration date of December 2013. Lot codes for kits distributed outside the United States are 03113A, 04213A, and 04813B.
The U.S. Food and Drug Administration has classified this recall as Class III. This classification indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Healthcare facilities and users should stop using the affected kits and contact AdvanDx, Inc. for further instructions.
The recalled product
- Product
- AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly
- Manufacturer
- AdvanDx, Inc.
- Hazard
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 codes US: 04813C
- 7413
- 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B
Distribution
Related recalls
Same manufacturer · AdvanDx, Inc.
See all →- ModerateAdvandx Quick FISH Fixation Kit Recalled for Quality Control Failure
FDA (Devices) · 2014-08-13
- ModerateAdvandx GNR Traffic Light PNA FISH Kit Recalled for False Positives
FDA (Devices) · 2012-10-31
- HighAdvandx E. coli/P. aeruginosa PNA FISH Kit Recalled for Cross-Reactivity
FDA (Devices) · 2012-10-31
Same hazard · incompatibility
See all →- ModerateZimmer Biomet Ceramic Hip Head 22.2 mm Lacks Stem Compatibility Information
FDA (Devices) · 2025-04-30
- ModerateZimmer Biomet Ceramic Hip Prosthesis Heads Lack Stem Compatibility Information
FDA (Devices) · 2025-04-30
- HighAMT Mini Enteral Extension Set Recalled for Incorrect Connector Type
FDA (Devices) · 2025-01-15
- HighPerfusor Space infusion pump syringe incompatibility may cause dosing error
FDA (Devices) · 2024-07-31
- HighINOmax DSIR Delivery System incompatible with upgraded Leoni Plus ventilator
FDA (Devices) · 2022-09-21