Recall Z-2455-2024 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 | Jul 31, 2024 (initiated Jun 5, 2024) |
| Status | Open, Classified |
| Reason | There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2: calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely. |
| Root cause | Software design |
| Action | During the week of June 20, 2024, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via email/postal mail to customers informing them of two software related issues associated with use of the Clinical Chemistry Analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. This may cause a false low resu |
| 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, and 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 |