FDA-Device2026-01-14Class IIPROCESSING DEFECT

Beckman Coulter UniCel Dxl 800 analyzer recalled for restart communication issue

OTHERNationwide distributionMedical devices

What this means

Beckman Coulter UniCel Dxl 800 analyzers (part numbers 973100, A71456, A71457, A25288) may fail to restart after shutdown due to a communication issue. When this happens, the analyzer cannot initialize or process patient samples, QCs, or calibrators, which delays test results.

If you operate one of these analyzers, contact Beckman Coulter immediately for instructions
Do not attempt repeated restart cycles; contact support first
Have an alternative testing method ready in case your analyzer is affected

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The agency's original wording

Hazard

Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cabo Verde, Canada, Chile, China, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Egypt, El Salvador, Eswatini, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Moldova, Republic of, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam, and Zimbabwe.

Affected count

6457 units

Manufactured in

1000 Lake Hazeltine Dr, Chaska, MN, United States

Products

Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1026-2026

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