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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83732

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

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Event summary

Timeline bucket
November 09, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
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 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255

Z-0492-2020
Recall number
Z-0492-2020
Initiated
November 09, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Beckman Coulter Inc.
Quantity
83 automate systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out occurred between the system and Laboratory Information System (LIS) .

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out occurred between the system and Laboratory Information System (LIS) .

Code information

All units containing software Version(s) 4.1.1 and up

Distribution pattern

US: NY, VA OUS: Austria Belgium Czech Republic France Germany Israel Italy Lithuania Mayotte Romania Slovakia South Africa Spain Sweden Switzerland United Kingdom