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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65655

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

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Event summary

Timeline bucket
September 22, 2010
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

ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.

Z-1951-2013
Recall number
Z-1951-2013
Initiated
September 22, 2010
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
718 units total (132 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments.

Code information

Lot No. T006042

Distribution pattern

Worldwide Distribution - USA Nationwide and the countries of Belgium, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, and United Kingdom