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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67069

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

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Event summary

Timeline bucket
December 11, 2013
Product types
Device
Classifications
Class III
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 Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures

Z-0619-2014
Recall number
Z-0619-2014
Initiated
December 11, 2013
Classification
Class III
Status
Terminated
Recalling firm
AdvanDx, Inc.
Quantity
49 kits US; 17 kits OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Kits incompatible with certain fluorescence microscope light sources

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits incompatible with certain fluorescence microscope light sources

Code information

Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B

Distribution pattern

Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.