Recall Z-0784-2024 ยท LKM Counter, Urine Particle
Beckman Coulter, Inc.
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
| Date | Jan 25, 2024 (initiated Dec 19, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Other |
| Action | 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 Trouble |
| Quantity | 254 units |
| Distribution | US and Australia, Brazil, Canada, China, France, Germany, Ghana, India, Israel, Italy, Lebanon, Lithuania, Mexico, Panama, Qatar, Romania, Saudi Arabia, Spain, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022774 | IQ 200 SYSTEM Intl. Remote Imaging Systems, Oct 21, 2002 |