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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70898

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

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Event summary

Timeline bucket
April 01, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Dako North America 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

Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests from LIS or manual entries to connected Dako systems.

Z-1548-2015
Recall number
Z-1548-2015
Initiated
April 01, 2015
Classification
Class II
Status
Terminated
Recalling firm
Dako North America Inc.
Quantity
33 (7 in U.S. and 26 Internationally)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software will reject the update. The LIS and printed slide label will

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

If a user requests slides from the LIS or TPID, then updates a request by changing the test, the TRD software will reject the update. The LIS and printed slide label will display the updated test with the requested change, but the Omnis system will execute the initial test, not reflecting the change. The system will not warn the user that the test request was rejected.

Code information

N/A Serial Number: 1311004352, 1308004862, 1307000537, 1405002266, 1410008844, 1307006995, 1311001075, 1402002186, 1401010308, 1402005995, 1306001697, 1311007317, 1410004066, 1404006200, 1410004067, 1405002263, 1404007225, 1410002144, 1311007321, 1404004226, 1401005960, 1305006010, 1401000919, 1405000371, 1401005963, 1403005465, 1304008205, 1401003711, 1401001048, 1310010425, 1401003715, 1311004354, 1311004355

Distribution pattern

Worldwide Distribution - U.S Nationwide in the states of IN and PA and the countries of: Spain, Belgium, France, Netherlands, Denmark, Finland, Sweden, Germany, UK, and Korea.