FDA-Device2026-01-14Class IIPROCESSING DEFECT

Beckman Coulter UniCel DxL 600 analyzer recalled for restart failure

OTHERNationwide distributionMedical devices

What this means

Certain Beckman Coulter UniCel DxL 600 analyzers may fail to restart properly after shutdown due to a communication issue. When this happens, the analyzer cannot process patient samples or quality control checks, which can delay test results.

If you operate one of the affected analyzers (part numbers A71460, A71461, or A30260), contact Beckman Coulter immediately
Do not rely on the analyzer to process samples until you receive guidance from Beckman Coulter
Have backup testing procedures in place while the issue is being resolved

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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

1272 units

Manufactured in

1000 Lake Hazeltine Dr, Chaska, MN, United States

Products

Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1025-2026

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