Recall Z-2691-2024 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Mishima K.K.
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
| Date | Aug 21, 2024 (initiated Jul 10, 2024) |
| Status | Open, Classified |
| Reason | Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results. |
| Root cause | Software design |
| Action | during the week of 07/25/2024, the firm sent an "URGENT MEDICAL DEVICE RECALL" letter via email and postal mail to customers informing them that after the analyzer processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and an error code "9000" will be reported. Customer are instructed: . Monitor the rerun/reflex process if a rerun/reflex rack is held in the buffer area, manually retrieve the rack from the buffer area, manually order the rerun/reflex test and reload the sample onto the sample handler. Refer to |
| Quantity | 24 analyzers |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of AL, CA, GA, HI, IL, MI, MN, MS, NE, NY, OR, PA and SC. The countries of Lebanon, South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., Jul 20, 2023 |