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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82919

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

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Event summary

Timeline bucket
September 17, 2018
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

Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year educational License (G) Kaluza C 10 User Network Educational License (H) Kaluza C 5 User Network Educational License (I) Kaluza C Flow Cytometry Software

Z-1982-2019
Recall number
Z-1982-2019
Initiated
September 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
41 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
issue between the software

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results.

Code information

A. C10574/UDI: 15099590705084 B. C10575/UDI: 15099590705091 C. C10576/UDI: 15099590705114 D. C10577/UDI: 15099590705107 E. C10578/UDI: 15099590705121 F. C10579/UDI: 15099590705138 G. C10580/UDI: 15099590705145 H. C10581/UDI: 15099590705152 I. C21166/UDI: 15099590705169

Distribution pattern

US: CA and NY OUS: United Kingdom, Switzerland and Germany