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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97531

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

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Event summary

Timeline bucket
September 08, 2025
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

CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.

Z-0412-2026
Recall number
Z-0412-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Beckman Coulter, Inc.
Quantity
108 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May

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

Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.

Code information

All serial numbers between BE43003 through BJ18014, manufactured from 12/03/2021 to 04/15/2025. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.

Distribution pattern

Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN, MA, ME, MI, MN, MO, NY, OR, TN, UT, WA and the countries Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Mexico, Morocco, Netherlands, Poland, Portugal, Puerto Rico, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.