Z-2138-2014Class II

AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH...

Name: Z-2138-2014 AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH...
Creator: Advandx Inc
Published: 2014-07-04
License: https://open.fda.gov/license/

Advandx, Inc. / initiated 2014-07-04 / Terminated / root cause: manufacturing process

FDA source

Advandx Inc began a recall of AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately... on 2014-07-04. FDA classified it as Class II and gives the reason as "Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC". 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-2138-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-04
Posted: 2014-08-01
Terminated: 2014-09-30
Recalling firm: Advandx, Inc.
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)
Product code: NXX Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Reason for recall: Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: AdvanDx notified customers by e-mail on July 4, 2014 of the problem and advised to discontinue use of the QuickFISH Fixation Kits with Lot#04914. Replacement kits were immediately shipped to all of the affected customers. Questions contact local AdvanDx representative or Technical Support 1-866-376-0009, fax 1-781-376-0111 or e-mail: [email protected]. An acknowledgement of Receipt and Destruction of Materials requested to be completed.
Quantity in commerce: 10 kits
Distribution: Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.
Product codes and lots: Lot Number: 04914 Exp. Date: 2015-06

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2138-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2138-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-01

Product code NXX

K113371Class IStaphylococcus Quickfish BcAdvandx, Inc. / cleared 2012-04-03

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)