FDA DevicesClass II
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; ...
Published: January 14, 2026Recall ID: Z-1026-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Affected Products
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Additional Source Details
| Field | Value |
|---|---|
| City | Chaska |
| State | MN |
| Event id | 98070 |
| Address 1 | 1000 Lake Hazeltine Dr |
| Code info | 973100: UDI 15099590265373 (Chaska) and 16954701000412 (Suzhou); A71456: UDI 15099590369194; A71457: UDI 15099590369231; A25288: UDI 15099590194819 |
| Postal code | 55318-1037 |
| Report date | 20260114 |
| Product type | Devices |
| Product quantity | 6457 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251126 |
| Initial firm notification | Letter |
| Center classification date | 20260106 |
Overview
- Recalling FirmBeckman Coulter, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.