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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63215

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 14, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Advandx Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.

Z-0112-2013
Recall number
Z-0112-2013
Initiated
September 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Advandx Inc
Quantity
187 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva

Code information

Lot Numbers: 02012A-US Exp. Date: 4-2014; 0812A-US Exp. Date: 12-2013; 01212A-EU Exp. Date: 4-2012 00712A-EU Exp. Date: 12-2013

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.