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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72408

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

Open FDA event record

Event summary

Timeline bucket
October 13, 2015
Product types
Device
Classifications
Class II
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

Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.

Z-0239-2016
Recall number
Z-0239-2016
Initiated
October 13, 2015
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
11,406 units total (1,660 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.

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 is recalling the Access CEA reagent packs because they were filled incorrectly.

Code information

595027 595029

Distribution pattern

Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Egypt, France, Germany, Ghana, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Mexico, Morocco, Myanmar, Netherlands, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.