Advandx Inc

FDA recalling firm · 4 enforcement events · 4 product records · 2012–2014 · MA

Advandx Inc has 4 FDA enforcement events on this register (4 product records) between 2012 and 2014: 4 device; the busiest year was 2012 with 2.

0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in MA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
4 Jul 2014	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)	Device	Class II	1	Terminated
11 Dec 2013	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 from GNR-positive blood cultures	Device	Class III	1	Terminated
14 Sep 2012	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 assay intended for the identification of…	Device	Class II	1	Terminated
14 Sep 2012	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 identification of Escherichia coli and…	Device	Class II	1	Terminated

By type and class

Device4

Class II3

Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Advandx Inc by year initiated.

Questions and answers

How many FDA recalls has Advandx Inc had?

4 enforcement events (4 product records) on this register, 2012–2014: 4 device.

Are any Advandx Inc recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Advandx Inc recalls?

3 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.