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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74608

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

Open FDA event record

Event summary

Timeline bucket
July 06, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Dako Denmark A/S

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

EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.

Z-2330-2016
Recall number
Z-2330-2016
Initiated
July 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Dako Denmark A/S
Quantity
147 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.

Code information

K8002 Lot no: 10112879 K8004 Lot no: 10111463

Distribution pattern

Worldwide Distribution -- US, Canada, and Colombia.