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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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…
- 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
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