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

FDA device recall Z-1026-2026 · posted 2026-01-06 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

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.

Action taken

Beckman Coulter issued an "URGENT MEDICAL DEVICE RECALL" notice dated 11/19/2026 to its consignees on 11/26/2025 via US mail and email. The notice explained the issue, impact, and requested the following actions: -Follow the restart process documented in Section 2 of the "Unicel DxI Access Immunoassay System Instructions for Use." -If your analyzer continues to experience this issue, please contact Beckman Coulter Technical Support. -Beckman Coulter recommends posting this letter on or near the affected analyzers." - Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide them a copy of this letter." For questions: please contact Customer Support Center: http://www.beckmancoulter.com

Root cause

Device Design

Status

Open, Classified

Product code

JJE

Quantity affected

6457 units

Distribution

Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, B

Date initiated

2025-11-26

Date posted

2026-01-06

Location

Chaska, MN

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