Beckman Coulter Recalls UniCel DxI 800 Immunoassay Systems Due to Software Anomaly
Beckman Coulter is recalling UniCel DxI 800 Access Immunoassay Systems because a software anomaly may cause erroneous test results.
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: The recall involves a risk-of-harm product (medical device) where the software anomaly may cause erroneous test results, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling UniCel DxI 800 Access Immunoassay Systems. The affected units include part numbers 937100, A25288, A71456, and A25285. The recall involves 2,442 units total, with 784 units distributed in the United States and the remainder distributed worldwide.
The recall was initiated because Beckman Coulter received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results. The device is an in vitro diagnostic used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Healthcare facilities and laboratories should contact Beckman Coulter for instructions on how to address the software anomaly and ensure accurate test results.
The recalled product
- Product
- UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or
- Manufacturer
- Beckman Coulter Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Part Numbers: Dxl 800: 937100
- Dxl 800 Remanufactured: A25288
- Dxl 800 with spot B: A71456
- Dxl 800 Reconditioned: A25285.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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