Recall Z-0787-2024

Reason for recall

Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.

FDA-determined cause: Other

Action taken

Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/19/2023 via first class mail and email. The notice explained the issue, its impact on test results, and requested the following actions be taken: - Continue to run a complete Quality Control (QC) rack [including Iris Cleanser, Iris Diluent, iQ Focus and iQ Controls] as directed per iQ200 Series Instructions for Use (IFU) (300-4320 CE or 300-4321 EE) and DxU 850m and 840m Iris IFU (C49320 AB) - If the QC passes: o Run patient samples as routine - If the QC fails: o Refer to the IFU, Chapter 10 Troubleshooting; iQ200 Series IFU or DxU 850m and 840m Iris IFU o If the failure persists, contact your Beckman Coulter Representative - If a "Sequential Flags" Alarm displays: Refer to the IFU, Chapter 10; Alarm #25; iQ200 Series IFU or DxU 850 and 840m Iris IFU o If the alarm persists, contact your Beckman Coulter Representative Additional weekly action if using DxU 850m/840m Microscopy Analyzers: Visually inspect the iQClear Rinse Waste Well jets weekly for rust o If the iQClear shows rust on the rinse jets, contact your Beckman Coulter Representative Consult with your laboratory management to determine whether a retrospective review of results is necessary. For questions regarding this notice, please contact Customer Support Center or your local representative; From our website: http://www.beckmancoulter.com By phone: call 800-526-7694 in the United States and Canada. o Outside the United States and Canada, contact your local Beckman Coulter representative.