Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68774

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

Open FDA event record

Event summary

Timeline bucket
July 04, 2014
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 Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)

Z-2138-2014
Recall number
Z-2138-2014
Initiated
July 04, 2014
Classification
Class II
Status
Terminated
Recalling firm
Advandx Inc
Quantity
10 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC

Code information

Lot Number: 04914 Exp. Date: 2015-06

Distribution pattern

Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.