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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74559

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

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Event summary

Timeline bucket
June 27, 2016
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

The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.

Z-2247-2016
Recall number
Z-2247-2016
Initiated
June 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
4,221 units total (2,033 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.

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 has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.

Code information

All

Distribution pattern

Affected geographies: United Arab Emirates, Curacao, Angola, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Brunei, Canada, Switzerland, Colombia, Costa Rica, Czech Republic, Germany, Ecuador, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Ireland, India, Iraq, Italy, Jordan, Japan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Morocco, Macao, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Serbia, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Swaziland, Thailand, Tunisia, Turkey, Taiwan, China, United States of America (including Puerto Rico), Viet Nam, Mayotte, South Africa.