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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76054

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

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Event summary

Timeline bucket
December 21, 2016
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Beckman Coulter 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

AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.

Z-1040-2017
Recall number
Z-1040-2017
Initiated
December 21, 2016
Classification
Class III
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.

Code information

ODL25255-4437 ODL25255-4443 ODL25255-4444 ODL25255-4438

Distribution pattern

US Distribution to MD only.

Field note

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