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Terminated

AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number: KT007

FDA Recall Z-0490-2011 · Posted 2010-11-29

Recalling FirmAdvanDx, Inc.
Recall StatusTerminated
Product CodeJSS
Date Initiated2010-10-06
Date Terminated2011-06-06
Product Quantity260 units

Reason for Recall

Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH to produce a false positive red signal.

Firm Action

AdvanDx issued a customer letter dated October 6, 2010 with a PDF file of a new package insert and an acknowledgement form to fill out and return to AdvanDx. Customers were instructed to replace the package insert in any existing inventory with the enclosed package insert. Customers can contact AdvanDx technical support about this action at 1-866-376-0009.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribuition: Throughtout the US, and to the countries of Denmark, Italy, Sweden, and UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092236E.COLI/P. AERUGINOSA PNA FISHAdvandx, Inc. · 2009-12-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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