The Recall Desk

Manufacturer

AdvanDx, Inc.

4 recalls in our database name AdvanDx, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2014-08-13

Of the 4 recalls from AdvanDx, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • ModerateFDA (Devices)·Z-2138-2014·2014-08-13

    Advandx Quick FISH Fixation Kit Recalled for Quality Control Failure

    Advandx Inc is recalling 10 kits of the Quick FISH Fixation Kit for Blood Cultures because they failed internal quality control tests.

    Product
    AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-0619-2014·2014-01-08

    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.

    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
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0116-2013·2012-10-31

    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.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0112-2013·2012-10-31

    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.

    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 as
    Category
    Medical Device
    Distribution
    Distributed nationwide