Z-0116-2013Class II

AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli...

Name: Z-0116-2013 AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli...
Creator: Advandx Inc
Published: 2012-09-14
License: https://open.fda.gov/license/

Advandx, Inc. / initiated 2012-09-14 / Terminated / root cause: manufacturing process

FDA source

Advandx Inc began a recall of AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007... on 2012-09-14. FDA classified it as Class II and gives the reason as "Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive...". 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-0116-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-14
Posted: 2012-10-22
Terminated: 2013-03-05
Recalling firm: Advandx, Inc.
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 identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
Product code: JSS Kit, Identification, Enterobacteriaceae
Reason for recall: Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal
Root cause tag: manufacturing process
FDA root cause: Process design
Action: AdvanDx notified customers on September 14, 2012 by email along with a PDF file of the new package insert to each contact followed by written notification and a paper copy of the new package insert via FedEx courier. The notification described the product, problem and actions to be taken. The customers were instructed to destroy the package insert in any existing inventory of the kit and replace it with the enclosed package insert. "Note: All shipments of E. coli/P.aeruginosa PNA FISH as of September 14, 2012, will contain this new package insert." The customers were also instructed to complete and return the Acknowledgement of Receipt form to AdvanDX: Regulatory Affairs; 400 TradeCenter, Suite 6990, Woburn, MA 01801-7476; Fax to: +1 (781) 376-0111; [email protected]. If you have any questions or requests for further information, please contact AdvanDx Technical Support: US (Toll-Free): 1-866-376-0009, [email protected].
Quantity in commerce: 33 units
Distribution: Worldwide distribution: USA (nationwide) including: CA, FL, IL, MI, and NJ; and country of: Great Britain.
Product codes and lots: Lot Numbers: 01812A-US, 03412A-US and 00512A-EU Exp Date: 12-2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0116-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0116-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-22

Product code JSS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)