Beckman Coulter Recalls DxC 600/800 Analyzers Due to Software Alignment Issue
Beckman Coulter is recalling 7 UniCel DxC 600/800 analyzers because software v5.0.11 prevents operators from performing a necessary alignment procedure.
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, but the source text describes a software limitation preventing a maintenance procedure rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling 7 units of the UniCel DxC 600/800 clinical chemistry analyzers equipped with software version 5.0.11. The recall involves specific serial numbers (2329, 5477, 5479) and Part Number B12218. These devices are fully automated systems used for in vitro determination of general chemistries and therapeutic drugs.
The recall was initiated because the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with this specific software version installed. If the Shuttle to Barcode Reader becomes misaligned, operators are unable to perform the required alignment procedure, which may affect the device's functionality.
The affected units were distributed worldwide, including in the United States (Texas and Ohio) and internationally to China and Turkey. Beckman Coulter is the recalling firm. Users of these specific analyzers should contact Beckman Coulter for further instructions regarding the software limitation.
The recalled product
- Product
- UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 7
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)
- Part Number B12218. Serial numbers 2329
- 5477
- 5479.
Distribution
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