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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63632

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

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Event summary

Timeline bucket
November 01, 2012
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 Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access  81600; Access 2  81600N, 386220, A69186, A25656, A12900; Access 2 (LXi)  A15642; Access 2 Section, DxC 600i  A25640. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.

Z-0612-2013
Recall number
Z-0612-2013
Initiated
November 01, 2012
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
6,858 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.

Code information

Part Numbers: Access  81600; Access 2  81600N, 386220, A69186, A25656, A12900; Access 2 (LXi)  A15642; Access 2 Section, DxC 600i  A25640

Distribution pattern

Worldwide Distribution-USA (nationwide) and the country of Canada.