Recall Z-0025-2025 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
| Date | Oct 7, 2024 (initiated Apr 18, 2024) |
| Status | Open, Classified |
| Reason | When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians. |
| Root cause | Software design |
| Action | The recalling firm issued letters dated 4/12/2024 on 4/18/2024 via first class mail. The letter described the issue, the impact, and actions to be taken, which included: (a) Verify the calibrator material expiration date before ordering a calibration on the analyzer; (b) Cancel calibration orders after the calibrator lot material expires. Instructions for canceling a calibration order are provided in the device help system or in the Calibration section of the IFU; (c) Repeat any test results generated from a calibration curve that used expired calibrator lot material. The resolution prov |
| Quantity | 164 units |
| Distribution | Distribution was made to FL, GA, IN, KS, NH, NJ, OK, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand |
| 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 |