Beckman Coulter Recalls Power Processor 1K Stockyard Due to Software Error
Beckman Coulter is recalling 27 Power Processor 1K Stockyard units because a software error may cause sample tubes to be retrieved during rack loading.
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 does not report any injuries, illnesses, or hospitalizations. The hazard is a functional software error that may disrupt the sample preparation process, fitting the criteria for a moderate severity recall without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling 27 units of the Power Processor 1K Stockyard. This device is used to perform pre-analytical sample tube preparation. The recall is due to a nonconformity in the PLC software (version V26R10).
The software issue can cause the 1K Stockyard to initiate the retrieval of a sample tube during the rack loading process, an action that should not occur. The issue and associated complaint were discovered and filed internally by the manufacturer.
The affected units were distributed in China, France, Italy, Kuwait, Spain, Turkey, and the United States. Users of this equipment should contact Beckman Coulter for further instructions on how to address the software nonconformity.
The recalled product
- Product
- Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 27
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)
- Software version PLC V26R10
Distribution
Distribution scope not specified by the agency.
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