Z-0619-2014Class III

AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog...

Name: Z-0619-2014 AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog...
Creator: AdvanDx, Inc.
Published: 2013-12-11
License: https://open.fda.gov/license/

Advandx, Inc. / initiated 2013-12-11 / Terminated / root cause: manufacturing process

FDA source

AdvanDx, Inc. began a recall of AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC... on 2013-12-11. FDA classified it as Class III and gives the reason as "Kits incompatible with certain fluorescence microscope light sources". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0619-2014
Classification: Class III
Status: Terminated
Initiated: 2013-12-11
Posted: 2014-01-02
Terminated: 2014-01-13
Recalling firm: Advandx, Inc.
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 from GNR-positive blood cultures
Product code: JSS Kit, Identification, Enterobacteriaceae
Reason for recall: Kits incompatible with certain fluorescence microscope light sources
Root cause tag: manufacturing process
FDA root cause: Process design
Action: AdvanDx issued an email notification along with a PDF file of the new package insert to each customer followed by written notification dated December 6, 2013 and a paper copy of the new package insert via Fed Ex courier. All customers received an acknowledgement form to fill out and return to AdvanDx so that the effectiveness of the replacement can be evaluated. All existing inventory of Gram-Negative QuickFISH BC will be repackaged with the new package inert Customers with questions were instructed to contact AdvanDx Technical Support at 1-866-376-0009 or [email protected]. For questions regarding this recall call 781-376-0009.
Quantity in commerce: 49 kits US; 17 kits OUS
Distribution: Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
Product codes and lots: Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0619-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0619-2014	Class III	Terminated	Voluntary: Firm initiated	2014-01-08	2014-01-02

Product code JSS

K123418Class IGram-Negative Quickfish BcAdvandx, Inc. / cleared 2013-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)