Advandx Inc: Medical Device Recall in 2012 - (Recall #: Z-0116-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 14, 2012

Date Posted: October 31, 2012

Recall Number: Z-0116-2013

Event ID: 63199

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

Status: Terminated

Product Quantity: 33 units

Code Information:

Lot Numbers: 01812A-US, 03412A-US and 00512A-EU Exp Date: 12-2013

Distribution Pattern:

Worldwide distribution: USA (nationwide) including: CA, FL, IL, MI, and NJ; and country of: Great Britain.

Voluntary or Mandated:

Voluntary: Firm initiated