Beckman Coulter Recalls Unicel Closed Tube Aliquotter Units Due to Hardware Error
Beckman Coulter is recalling 18 Unicel Closed Tube Aliquotter units because a hardware motion error may occur. The recall covers units distributed in the US and several international locations.
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 is a hardware motion error with no reported injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling 18 units of the Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, 680i, 860i, and 880i Synchron Access Clinical Systems. The affected units have serial numbers between 547 and 574 and are identified by Part Number A45853. These devices are used in fully automated, computer-controlled clinical chemistry analyzers for in-vitro determination of various chemistries.
The recall was initiated because Beckman Coulter confirmed that the current sample syringe pump drive assemblies installed on these specific DxC Integrated System units may cause a hardware motion error, identified as ID0x08000501. This defect is a hardware issue that may affect the operation of the aliquotter.
The affected units were distributed worldwide, including in the United States (nationwide) and in China, France, Italy, and Taiwan. Users of these clinical systems should contact Beckman Coulter for instructions on how to address the hardware motion error.
The recalled product
- Product
- Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 18
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)
- Serial Numbers: 547-574 (UCTA)
Distribution
Distributed nationwide across the United States.
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