Clinical Chemistry Analyzer Software Bugs May Cause Erroneous Patient Results
Beckman Coulter's DxC 500 AU analyzer has two software bugs that may cause erroneous patient results due to misreported calibrations or expired reagents. No injuries or illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with software defects that may cause erroneous patient results. The manufacturer explicitly states the probability of serious adverse health consequences or death is unlikely, and no illnesses or injuries have been reported. As a risk-of-harm product without reported harm to date, this meets the High severity criterion.
Plain-English summary
Beckman Coulter Mishima K.K. is recalling 24 units of the DxC 500 AU Clinical Chemistry Analyzer (Catalog Number C63520) due to two software issues.
Issue 1: When a dedicated rack is reserved for calibration, after calibration placement and completion, the same rack may be used for both a patient order and a calibration order. If a patient sample and a non-barcoded calibrator tube are processed together on the rack, the calibration result will be reported as a patient result. Issue 2: The analyzer may perform calibration using expired calibrator material. Both issues may cause erroneous patient results. The manufacturer states that the probability of serious adverse health consequences or death is unlikely.
The recalled analyzers were distributed to clinical laboratories in Alabama, California, Georgia, Hawaii, Illinois, Michigan, Minnesota, Mississippi, Nebraska, New York, Oregon, Pennsylvania, and South Carolina in the United States, as well as to Lebanon and South Africa. Affected serial numbers include 2023070010, 2023060005, 2023090015, 2023070009, 2023080011, 2023080012, 2023100019, 2023100018, 2023100020, 2024010037, 2024010036, 2023110022, 2024010038, 2023090016, 2024020040, 2024020041, 2024020039, 2024020043, 2024020042, 2023110023, 2024020045, 2024020046, 2024010024, and 2024010025.
The recalled product
- Product
- 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.
- Manufacturer
- Beckman Coulter Mishima K.K.
- Hazard
- software-bug
- erroneous-patient-results
Distribution
Distributed nationwide across the United States.
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