Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A7... (Beckman Coulter, Inc.) – beckman coulter has determined that, ... (2025)
Analyzer communication issues can cause delayed medical test results.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Brand
Beckman Coulter, Inc.
Lot Codes / Batch Numbers
A71460: UDI 15099590369224 A71461: UDI 15099590369248 A30260: UDI 15099590341602
Products Sold
A71460: UDI 15099590369224 A71461: UDI 15099590369248 A30260: UDI 15099590341602
Beckman Coulter, Inc. is recalling Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin due to Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a stand. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026