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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88247

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

Open FDA event record

Event summary

Timeline bucket
June 23, 2021
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 Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpetual Educational License C10579 - Kaluza C Single User 1-year Educational License C10580 - Kaluza C 10 User Network Educational License C10581 - Kaluza C 5 User Network Educational License and C21166 - Kaluza C Program DVD v1.0

Z-2241-2021
Recall number
Z-2241-2021
Initiated
June 23, 2021
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter, Inc.
Quantity
1,085 (482 US & 603 OUS)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software anomalies

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software anomalies that may lead to the generation of erroneous results.

Code information

Versions: 1.0, 1.1.1 and 1.1.2

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, and Hawaii. The countries of Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Israel, Italy, Kenya, Korea, Kuwait, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Reunion, Saudi Arabia, Slovakia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, U.A.E, Ukraine, United Kingdom, and Vietnam.

Field note

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