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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95227

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

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Event summary

Timeline bucket
April 18, 2024
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

Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Z-0025-2025
Recall number
Z-0025-2025
Initiated
April 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Beckman Coulter, Inc.
Quantity
164 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.

Code information

UDI-DI: 15099590230623; U.S. serial numbers: 300284, 300286, 300294, 300266, 300291, 300223, 300260, 300285, 300292, 300195, 300227, 300228, 300205, 300207, 300206, 300182, 300192, and 300234. OUS serial numbers have been requested.

Distribution pattern

Distribution was made to FL, GA, IN, KS, NH, NJ, OK, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, and United Kingdom of Great Britain and Northern Ireland.

Field note

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