Beckman Coulter Recalls DxH 800 and DxH 600 Software Versions
Beckman Coulter is recalling specific software versions for its DxH 800 and DxH 600 hematology analyzers because the systems allow multiple orders to share the same specimen ID with 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect involves software data integrity rather than a direct physical hazard or reported illness, fitting the Moderate severity criteria for low-risk contamination or minor errors.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxH 800 Slidemaker Stainer Software version 3.0.2.0 and the UniCel DxH 600 software version 1.1.1.0. These products are quantitative, multi-parameter, automated hematology analyzers used for in vitro diagnostic purposes in clinical laboratories to screen patient populations.
The recall is being conducted because the software 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 in clinical laboratory settings.
The recall affects 834 units total, with 594 units distributed in the United States and the remainder distributed internationally to numerous countries including Australia, Canada, China, Germany, Japan, and the United Kingdom. Affected units are identified by Part No. 775222 and all serial numbers. Clinical laboratories and healthcare facilities should contact Beckman Coulter for instructions on how to address the software defect.
The recalled product
- Product
- UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical…
- 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 (1)
- all serial numbers Part No. 775222
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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