Recall Z-2264-2024 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
| Date | Jul 3, 2024 (initiated Apr 18, 2024) |
| Status | Open, Classified |
| Reason | Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyzer accepts calibrator values scanned from multiple calibrator cards when an operator configures a new calibrator lot. The analyzer accepts the calibrator lot values from any scanned calibrator card, regardless of the assay test code or cali |
| Root cause | Software design |
| Action | Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 04/18/2024 via USPS first class mail. The notice explained the issue, impact, and requested the following actions be taken: "x Confirm that the DxI 9000 Access Immunoassay Analyzer test name printed on the calibrator card matches the calibrator material name before you configure the calibrator lot. x Scan each individual calibrator card and complete each step displayed on the DxI 9000 Access Immunoassay Analyzer user interface before you scan the next calibrator card. x Review the expected values column on th |
| Quantity | 116 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer Beckman Coulter, Inc., Nov 10, 2022 |