Beckman Coulter Recalls DxH 800 and 600 Hematology Analyzer Software
Beckman Coulter is recalling specific software versions for its DxH 800 and DxH 600 hematology analyzers because the software allows the creation of multiple orders with the same specimen ID but different patient IDs.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software defect that allows duplicate specimen IDs with different patient IDs, which is a data integrity issue. No specific injuries, illnesses, or deaths are reported in the source text, and the risk is theoretical regarding patient safety outcomes, fitting the criteria for a moderate severity score.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, and the DxH 600 software version 1.1.1.0. These are quantitative, multi-parameter, automated hematology analyzers used for in vitro diagnostic purposes in clinical laboratories to screen patient populations. The recall involves 3,951 units total, with 1,975 units located in the United States and the remainder distributed internationally.
The recall is being conducted because the software for the DxH systems allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager. This defect could potentially lead to data integrity issues within the laboratory system.
The affected products are identified by Part Nos. 629029, B24465, and B24802. The recall covers all serial numbers for these part numbers. The products were distributed nationwide in the US and internationally to numerous countries including Australia, Canada, China, Germany, Japan, and the United Kingdom. Clinical laboratories should contact Beckman Coulter for instructions on how to address the software defect.
The recalled product
- Product
- UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found…
- 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 (3)
- all serial numbers Part Nos. 629029
- B24465
- B24802
Distribution
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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